Stevia extracts

ABSTRACT

A  Stevia  extract made from leaves of the  Stevia rebaudiana  plant is described. The extract has desired levels of steviol glycosides and is useful in food, beverage, and other consumable products.

RELATED APPLICATIONS

This patent application is a continuation of U.S. patent applicationSer. No. 15/507,969, filed Mar. 1, 2017, which is a 371 National Entryof PCT Application Number PCT/US2015/047234, filed Aug. 27, 2015, whichclaims priority under 35 U.S.C. § 119(e) to U.S. Provisional PatentApplication No. 62/044,626, filed on Sep. 2, 2014; U.S. ProvisionalApplication No. 62/059,562, filed on Oct. 3, 2014; U.S. ProvisionalPatent Application No. 62/061,363, filed on Oct. 8, 2014; and U.S.Provisional Patent Application No. 62/064,601, filed on Oct. 16, 2014;the contents of which applications are incorporated herein by reference.

TECHNICAL FIELD

The present invention relates to a process for preparing compositionscomprising steviol glycosides. The present invention also relates to theuse of compositions comprising steviol glycosides as sweeteners and/orflavor enhancers.

BACKGROUND OF THE INVENTION

High intensity sweeteners possess a sweetness level that is many timesgreater than the sweetness level of sucrose. They are essentiallynon-caloric and are commonly used in diet and reduced-calorie products,including foods and beverages. High intensity sweeteners do not elicit aglycemic response, making them suitable for use in products targeted todiabetics and others interested in controlling for their intake ofcarbohydrates.

Steviol glycosides are a class of compounds found in the leaves ofStevia rebaudiana Bertoni, a perennial shrub of the Asteraceae(Compositae) family native to certain regions of South America. They arecharacterized structurally by a single base, steviol, differing by thepresence of carbohydrate residues at positions C13 and C19. Theyaccumulate in Stevia leaves, composing approximately 10%-20% of thetotal dry weight. On a dry weight basis, the four major glycosides foundin the leaves of Stevia typically include stevioside (9.1%),rebaudioside A (3.8%), rebaudioside C (0.6-1.0%) and dulcoside A (0.3%).

Morita et al. 2011 (U.S. Ser. No. 13/122,232) and Ohta et al 2010 (OhtaM., Sasa S., Inoue A., Tamai T., Fujita I, Morita K., and Matsuura F.(2010) Characterization of novel steviol glycosides from leaves ofStevia rebaudiana Morita, J. Appl. Glycosci. 57, 199-209) describe thatrebaudiosides D, E, M N and O are found in trace concentrations in theleaves of certain Stevia rebaudiana Bertoni cultivars. Due to this thepurification of those glycosides, particularly rebaudiosides D, E, M, Nand O can be achieved only by utilizing complex purification techniquessuch as chromatography, crystallization etc.

It is generally perceived that the aqueous extracts of Stevia rebaudianaare not suitable for use in food and beverage applications withoutfurther treatment such as crystallization, separation, isolation andpurification of individual steviol glycosides. The reason for this isthe low concentration of better tasting glycosides, particularlyrebaudiosides D, E, M, N and O in regular extracts of Stevia rebaudiana.

Accordingly, there remains a need for new cultivars of Stevia rebaudianacontaining higher concentrations of rebaudiosides D, E, M, N and O,which can enable manufacturing of Stevia extracts with higherconcentrations of respective glycosides and their use as sweetenersand/or flavor ingredients without further treatment such ascrystallization, separation, isolation and purification of individualsteviol glycosides.

SUMMARY OF THE INVENTION

The present invention relates to a process for preparing compositionscomprising steviol glycosides from Stevia rebaudiana biomass. Thepresent invention also relates to the use of compositions comprisingsteviol glycosides as a sweetener and/or flavor enhancer.

Hereinafter the term “steviol glycoside(s)” will mean steviol glycosidesnaturally occurring in Stevia rebaudiana, including but not limited tosteviolmonoside, steviolbioside, rubusoside, dulcoside B, dulcoside A,rebaudioside B, rebaudioside G, stevioside, rebaudioside C, rebaudiosideF, rebaudioside A, rebaudioside I, rebaudioside E, rebaudioside H,rebaudioside L, rebaudioside K, rebaudioside J, rebaudioside M,rebaudioside D, rebaudioside N, rebaudioside O, and combinationsthereof.

Hereinafter the terms “RebA”, “RebB”, “RebC”, “RebD”, “RebE”, “RebF”,“RebM”, “RebN”, and “RebO” refer to Rebaudiosides A, B, C, D, E, F, M,N, and O.

Hereinafter the terms “RebD2”, “RebG”, “RebH”, “RebI”, “RebJ”, “RebK”,“RebL”, “RebM2”, “RebP”, “RebQ” “RebR”, RebS”, “RebT”, “RebU”, “RebV”,“RebW”, “RebX”, “RebY”, and “RebZ”, refer to Rebaudiosides D2, G, H, I,J, K, L, M2, P, Q, R, S, T, U, V, W, X, Y and Z.

Hereinafter the terms “Stev”, “Sbio”, “DulA”, “Rub”, refer toStevioside, Steviolbioside, Dulcoside A and Rubusoside.

Hereinafter the term “TSG content” will mean Total Steviol Glycosides(TSG) content, and it will be calculated as the sum of theconcentrations of Rebaudioside A, Rebaudioside B, Rebaudioside C,Rebaudioside D, Rebaudioside E, Rebaudioside F, Rebaudioside M,Rebaudioside N, Rebaudioside O, Stevioside, Steviolbioside, Dulcoside Aand Rubusoside on a wt/wt dry basis.

Hereinafter the term “relative concentration” will mean the percentratio of the concentration of Rebaudioside A, Rebaudioside B,Rebaudioside C, Rebaudioside D, Rebaudioside E, Rebaudioside F,Rebaudioside M, Rebaudioside N, Rebaudioside O, Stevioside,Steviolbioside, Dulcoside A or Rubusoside (on a wt/wt dry basis) toTotal Steviol Glycosides (TSG) content. For example if the compositioncomprises 10% RebO, 40% Stev, 0% RebA, 0% RebB, 0% RebC, 0% RebD, 0%RebE, 0% RebF, 0% RebM, 0% RebN, 0% Sbio, 0% DulA and 0% Rub (allconcentration being % wt/wt on dry basis) the TSG content of thecomposition will be 50% (wt/wt on dry basis). Since the concentration ofRebO is 10% (wt/wt on dry basis) the relative concentration of RebO willbe 20% and will be calculated as follows:Relative concentration of RebO (%)={concentration of RebO (% wt/wt ondry basis)/TSG content (% wt/wt on dry basis)}*100%

Similarly the relative concentrations of other glycosides can becalculated. The “common relative concentration” shall refer to therelative concentration of steviol glycosides occurring in knownvarieties and untreated aqueous extracts of Stevia rebaudiana plants. Asused herein, “untreated aqueous extract(s)” shall refer to an extract orextracts from Stevia rebaudiana plants that has or have not beensubjected to techniques used to purify, isolate or further concentrate acertain steviol glycoside, or a group of steviol glycosides, from theextract.

Hereinafter the term “relative ratio” will mean the ratio of theconcentration of one steviol glycoside to another. For example if thecomposition comprises 10% RebO, 40% Stev, 0% RebA, 0% RebB, 0% RebC, 0%RebD, 0% RebE, 0% RebF, 0% RebM, 0% RebN, 0% Sbio, 0% DulA and 0% Rub(all concentration being % wt/wt on dry basis) the relative ratio ofRebO to Stevioside will be 0.25 and will be calculated as follows:Relative ratio of RebO to Stev=concentration of RebO (% wt/wt on drybasis)/concentration of Stev (% wt/wt on dry basis)

In the invention, Stevia rebaudiana plant biomass, particularly the dryleaves, were used as a starting material. Optionally the leaves may benot dried as well. The leaves may be optionally ground into fine powder.However not only the leaves but also the other parts of the Steviarebaudiana plant such as stems, roots, flowers etc. or combinationsthereof may be used as starting material.

The process for preparing steviol glycosides compositions may comprisethe steps of:

a) providing Stevia rebaudiana leaves, wherein Stevia rebaudiana leavescomprise at least one steviol glycoside selected from the groupconsisting of RebE, RebM, RebD, RebN, and RebO, wherein the steviolglycoside is present above common relative concentration,

b) providing solvent;

c) contacting the Stevia rebaudiana leaves with solvent to extract thesteviol glycosides from the leaves;

d) separating the Stevia rebaudiana leaves to obtain Stevia extractsolution comprising at least one steviol glycoside selected from thegroup consisting of RebE, RebM, RebD, RebN, and RebO, wherein thesteviol glycoside is present above common relative concentration,HSG-Extract.

The solvent may be water, alcohol, aqueous alcohol, or any other solventknown to be used in production of Stevia extracts or plant extracts.

The process may further include other refining and purificationtechniques or processes known to be used in production of steviolglycosides. Non limiting examples include, flocculation, ion-exchangeresin treatment, membrane filtration, macroporous adsorption resintreatment, activated carbon treatment, chromatographic separation,crystallization, centrifugation, blending, drying, milling, sieving,granulation, agglomeration, solubilisation, in any order or stepnumbers.

The present invention provides stevia compositions called “HSG Extracts”comprising at least one of the steviol glycosides selected from thegroup including Rebaudioside E, Rebaudioside D, Rebaudioside M,Rebaudioside N, Rebaudioside O, or combinations thereof, wherein the atleast one of the steviol glycosides selected from the group includingRebE, RebD, RebM, RebN, RebO, is present in a relative concentrationhigher than the relative concentration occurring in known varietiesand/or untreated aqueous extracts of Stevia rebaudiana plant.

DETAILED DESCRIPTION

The present invention relates to a process for preparing compositionscomprising steviol glycosides from Stevia rebaudiana biomass. Thepresent invention also relates to the use of compositions comprisingsteviol glycosides as a sweetener and/or flavor enhancer.

The present invention provides new cultivars of Stevia rebaudiana plant,comprising at least one of the steviol glycosides selected from thegroup including Rebaudioside E, Rebaudioside D, Rebaudioside M,Rebaudioside N, Rebaudioside O, or combinations thereof, wherein the atleast one of the steviol glycosides selected from the group includingRebE, RebD, RebM, RebN, RebO, is present in a relative concentrationhigher than the relative concentration occurring in known varieties anduntreated aqueous extracts of Stevia rebaudiana plant.

In a particular embodiment the new cultivars are the cultivars namedStevia rebaudiana 814011, 807086, 817096, which are obtained byselective breeding of Stevia rebaudiana Bertoni plant.

Generation of Stevia plants with the desirable characteristics describedherein can be accomplished by growing from the callus culture depositedat China General Microbiological Culture Center (CGMCC, Institute ofMicrobiology, Chinese Academy of Sciences, Datun Road, ChaoyangDistrict, Beijing 100101, China; Tel.: 86-10-64807355, Fax:86-10-64807288), and assigned deposit No. 9701 for Stevia rebaudianacultivar 814011, No. 9702 for Stevia rebaudiana cultivar 807086, and No.9703 for Stevia rebaudiana cultivar 817096.

It is also possible to generate varieties and lines of Stevia using atleast one of the deposited lines by either conventional cross breedingtechniques or molecular techniques to transfer one or more geneticelements (genes, promoters, protein coding sequences, and the like) toother Stevia plants.

Alternatively, it is possible to generate new Stevia plants througheither classical selection and cross breeding alone, or in combinationwith chemical or radiation induced mutation using at least one Steviarebaudiana cultivar selected from group including 814011, 807086, 817096and/or seeds thereof.

In one embodiment, new cultivars of Stevia rebaudiana plants are F1, F2,F3, or subsequent progeny of at least one Stevia rebaudiana cultivarselected from group including 814011, 807086, 817096.

In another embodiment, high rebD plants are the first generation orsubsequent progeny of at least one Stevia rebaudiana cultivar selectedfrom group including 814011, 807086, 817096 whose seeds were subjectedto chemical or radiation mutagenesis.

In another embodiment, a method of cross breeding new high RebMcultivars of Stevia rebaudiana is disclosed. In said cross breedingmethod one parent plant is a cultivar having low rebM, high RebE andhigh RebD content (e.g. 817096) and the other parent is a cultivarhaving high rebM content (e.g. 814011).

In one embodiment, new high RebM cultivars of Stevia rebaudiana plantsare F1, F2, F3, or subsequent progeny of Stevia rebaudiana cultivars814011 and 817096.

In a particular embodiment the relative concentration of RebE in driedleaves of new Stevia rebaudiana cultivar is at least 1.0%.

In a particular embodiment the relative concentration of RebM in driedleaves of new Stevia rebaudiana cultivar is at least 1.4%.

In a particular embodiment the relative concentration of RebD in driedleaves of new Stevia rebaudiana cultivar is at least 2.4%.

In a particular embodiment the relative concentration of RebN in driedleaves of new Stevia rebaudiana cultivar is at least 1.6%.

In a particular embodiment the relative concentration of RebO in driedleaves of new Stevia rebaudiana cultivar is at least 0.8%.

In a particular embodiment the relative concentration of at least oncompound selected from the group including RebD2, RebG, RebH, RebI,RebJ, RebK, RebL, RebM2, RebP, RebQ RebR, RebS, RebT, RebU, RebV, RebW,RebX, RebY, RebZ, and other glycoside of steviol in dried leaves of newStevia rebaudiana cultivar is at least 0.1%.

In one embodiment the dried leaves of at least one Stevia rebaudianacultivar selected from group 814011, 807086, 817096 are subjected toaqueous extraction (e.g. according to procedure described in U.S. Ser.No. 13/122,232) to prepare stevia compositions called “HSG-Extracts”.Any other extraction method can be used as well.

The present invention provides stevia compositions called “HSG-Extracts”comprising at least one steviol glycoside selected from the groupconsisting of RebE, RebM, RebD, RebN, and RebO, wherein the steviolglycoside is present above common relative concentration occurring inknown varieties and untreated aqueous extracts of Stevia rebaudianaplant, and wherein for RebE this common relative concentration is 1.0%,for RebM 1.4%, for RebD 2.4%, for RebN 1.6%, and for RebO 0.8%.

In a particular embodiment the relative concentration of RebE in“HSG-Extract”, produced by aqueous extraction of dried leaves of newStevia rebaudiana cultivar is at least 1.0%.

In a particular embodiment the relative concentration of RebM in“HSG-Extract”, produced by aqueous extraction of dried leaves of newStevia rebaudiana cultivar is at least 1.4%.

In a particular embodiment the relative concentration of RebD in“HSG-Extract”, produced by aqueous extraction of dried leaves of newStevia rebaudiana cultivar is at least 2.4%.

In a particular embodiment the relative concentration of RebN in“HSG-Extract”, produced by aqueous extraction of dried leaves of newStevia rebaudiana cultivar is at least 1.6%.

In a particular embodiment the relative concentration of RebO in“HSG-Extract”, produced by aqueous extraction of dried leaves of newStevia rebaudiana cultivar is at least 0.8%.

In a particular embodiment the relative concentration of at least oncompound selected from the group including RebD2, RebG, RebH, RebI,RebJ, RebK, RebL, RebM2, RebP, RebQ RebR, RebS, RebT, RebU, RebV, RebW,RebX, RebY, RebZ, and other glycoside of steviol in “HSG-Extract”,produced by aqueous extraction of dried leaves of new Stevia rebaudianacultivar is at least 0.1%.

Optionally, the method of the present invention further comprisespurifying RebE, RebM, RebD, RebN, and RebO from the HSG-Extract. Anysuitable purification method can be used, such as, for example,crystallization, separation by membranes, centrifugation, extraction(liquid or solid phase), chromatographic separation, HPLC (preparativeor analytical) or a combination of such methods.

In one embodiment, the HSG-Extract is provided as part of a mixture. Ina particular embodiment, the mixture is selected from the groupconsisting of a mixture of steviol glycosides, a Stevia extract,by-products of other steviol glycosides' isolation and purificationprocesses, or any combination thereof. In one embodiment, the mixturecontains HSG-Extract in an amount that ranges from about 10% to about99% by weight on a dry basis, such as, for example, from about 20% toabout 99%, from about 30% to about 99%, from about 40% to about 99%,from about 50% to about 99%, from about 60% to about 99%, from about 70%to about 99%, from about 80% to about 99% and from about 90% to about99%. In a particular embodiment, the mixture contains HSG-Extract in anamount greater than about 90% by weight on a dry basis, for example,greater than about 91%, greater than about 92%, greater than about 93%,greater than about 94%, greater than about 95%, greater than about 96%,greater than about 97%, greater than about 98% and greater than about99%.

In one embodiment the HSG-extract contains one or more additionalsteviol glycosides including, but not limited to, naturally occurringsteviol glycosides, e.g. steviolmonoside, steviolbioside, rubusoside,dulcoside B, dulcoside A, rebaudioside B, rebaudioside G, stevioside,rebaudioside C, rebaudioside F, rebaudioside A, rebaudioside I,rebaudioside E, rebaudioside H, rebaudioside L, rebaudioside K,rebaudioside J, rebaudioside M, rebaudioside M2, rebaudioside D,rebaudioside D2, rebaudioside N, rebaudioside O, synthetic steviolglycosides, e.g. enzymatically glucosylated steviol glycosides andcombinations thereof.

HSG-Extract can be present in the composition in an amount effective toprovide a concentration from about 1 ppm to about 10,000 ppm when thecomposition is added to a consumable, such as, for example, from about 1ppm to about 4,000 ppm, from about 1 ppm to about 3,000 ppm, from about1 ppm to about 2,000 ppm, from about 1 ppm to about 1,000 ppm. Inanother embodiment, a HSG-Extract is present in the composition in anamount effective to provide a concentration from about 10 ppm to about1,000 ppm when the composition is added to a consumable, such as, forexample, from about 10 ppm to about 800 ppm, from about 50 ppm to about800 ppm, from about 50 ppm to about 600 ppm or from about 200 ppm toabout 250 ppm. In a particular embodiment, HSG-Extract is present in thecomposition in an amount effective to provide a concentration from about300 ppm to about 600 ppm when the composition is added to a consumable.

Sweetener Compositions

In one embodiment, the present invention is a sweetener compositioncomprising HSG-Extract.

“Sweetener composition,” as used herein, refers to a composition usefulto sweeten a sweetenable composition (i.e. a composition that can besweetened) that contains at least one sweet component in combinationwith at least one other substance.

In one embodiment, HSG-Extract is the sole sweetener in the sweetenercomposition, i.e. HSG-Extract is the only compound present in thesweetener composition that provides a detectable sweetness. In anotherembodiment, the sweetener composition includes a compound of HSG-Extractin combination with one or more sweetener compounds.

The amount of HSG-Extract in the sweetener composition may vary. In oneembodiment, HSG-Extract is present in a sweetener composition in anyamount to impart the desired sweetness when the sweetener composition isadded to a sweetenable composition or sweetenable consumable.

The sweetness of a non-sucrose sweetener can also be measured against asucrose reference by determining the non-sucrose sweetener's sucroseequivalence. Typically, taste panelists are trained to detect sweetnessof reference sucrose solutions containing between 1-15% sucrose (w/v).Other non-sucrose sweeteners are then tasted at a series of dilutions todetermine the concentration of the non-sucrose sweetener that is assweet as a given percent sucrose reference. For example, if a 1%solution of a sweetener is as sweet as a 10% sucrose solution, then thesweetener is said to be 10 times as potent as sucrose.

In one embodiment, HSG-Extract is present in the sweetener compositionin an amount effective to provide a sucrose equivalence of greater thanabout 10% (w/v) when the sweetener composition is added to a sweetenablecomposition or sweetenable consumable, such as, for example, greaterthan about 11%, greater than about 12%, greater than about 13% orgreater than about 14%.

The amount of sucrose, and thus another measure of sweetness, in areference solution may be described in degrees Brix (° Bx). One degreeBrix is 1 gram of sucrose in 100 grams of solution and represents thestrength of the solution as percentage by weight (% w/w) (strictlyspeaking, by mass). In one embodiment, a sweetener composition comprisesHSG-Extract in an amount effective to provide sweetness equivalent fromabout 0.50 to 14 degrees Brix of sugar when present in a sweetenedcomposition, such as, for example, from about 5 to about 11 degreesBrix, from about 4 to about 7 degrees Brix, or about 5 degrees Brix. Inyet another embodiment a composition comprising HSG-Extract is presentwith at least one other sweetener in an amount effective to provide anyone of the sweetness equivalents listed above.

In one embodiment, HSG-Extract is present in the sweetener compositionin an amount effective to provide a concentration from about 1 ppm toabout 10,000 ppm when the sweetener composition is added to a consumable(e.g., a beverage), such as, for example, from about 1 ppm to about4,000 ppm, from about 1 ppm to about 3,000 ppm, from about 1 ppm toabout 2,000 ppm, from about 1 ppm to about 1,000 ppm. In anotherembodiment, HSG-Extract is present in the sweetener composition in anamount effective to provide a concentration from about 10 ppm to about1,000 ppm when the composition is added to a consumable, such as, forexample, from about 10 ppm to about 800 ppm, from about 50 ppm to about800 ppm, from about 50 ppm to about 600 ppm or from about 200 ppm toabout 250 ppm. In a particular embodiment, HSG-Extract is present in thesweetener composition in an amount effective to provide a concentrationfrom about 300 ppm to about 600 ppm when the sweetener composition isadded to the consumable.

In some embodiments, HSG-Extract is present in the sweetener compositionin an amount effective to provide a concentration of the compound thatis above, at or below its threshold sweetener recognition level when thesweetener composition is added to a consumable (e.g., a beverage).

Flavor Enhancing Compositions

In one aspect, the present invention is a flavor enhancing compositioncomprising HSG-Extract.

“Flavor enhancer compositions,” as used herein, refers to a compositioncapable of enhancing or intensifying the perception of a particularflavor in a consumable. The terms “flavor enhancing compositions” or“flavor enhancer” are synonymous with the terms “flavor potentiator,”“flavor amplifier,” and “flavor intensifier.” Generally, the flavorenhancing composition provided herein may enhance or potentiate thetaste of flavor ingredients, i.e. any substance that provides sweetness,sourness, saltiness, savoriness, bitterness, metallic taste,astringency, sweet lingering aftertaste, sweetness onset, etc. Withoutbeing bound by any theory, the flavor enhancing composition likely doesnot contribute any noticeable taste to the consumable to which it isadded because HSG-Extract is present in the consumable in aconcentration at or below its flavor recognition thresholdconcentration.

“Flavor recognition threshold concentration,” as used herein, refers tothe lowest concentration at which the particular flavor or off-taste ofa component (e.g., a compound) is perceptible in a consumable. Theflavor recognition threshold concentration varies for differentcompounds, and may be varied with respect to the individual perceivingthe flavor or the particular consumable.

In one embodiment, the flavor enhancing composition comprisesHSG-Extract in an amount effective to provide a concentration that is ator below the threshold flavor recognition concentration of HSG-Extractwhen the flavor enhancing composition is added to a consumable.

In a particular embodiment, HSG-Extract is present in theflavor-enhancing composition in an amount effective to provide aconcentration that is below the threshold flavor recognitionconcentration of HSG-Extract when the flavor enhancing composition isadded to a consumable.

In certain embodiment, HSG-Extract is present in the flavor enhancingcomposition in an amount effective to provide a concentration that is atleast about 1%, at least about 5%, at least about 10%, at least about15%, at least about 20%, at least about 25%, at least about 30%, atleast about 35%, at least about 40%, at least about 45% or at leastabout 50% or more below the threshold flavor recognition concentrationwhen the flavor enhancing composition is added to a consumable.

In some embodiments, HSG-Extract is present in the flavor enhancingcomposition in an amount that, when added to the consumable, willprovide a concentration of ranging from about 0.5 ppm to about 1000 ppm.For example, HSG-Extract is present in the composition in an amountthat, when added to the consumable, will provide a concentration rangingfrom about 1 ppm to about 300 ppm, from about 0.1 ppm to about 75 ppm,or from about 500 ppm to about 3,000 ppm.

A person of skill in the art will be able to select the concentration ofHSG-Extract in the flavor enhancing composition so that it may impart anenhanced flavor to a consumable comprising at least one flavoringredient. For example, a skilled artisan may select a concentrationfor HSG-Extract in the flavor enhancing composition so that the flavorenhancing composition and/or the HSG-Extract does not impart anyperceptible flavor to a consumable when the flavor enhancing compositionis added thereto.

In one embodiment, addition of the flavor enhancing compositionincreases the detected flavor of the at least one flavor ingredient inthe consumable compared to the detected flavor of the same ingredient inthe consumable in the absence of the flavor enhancer.

Suitable flavor ingredients include, but are not limited to, vanillin,vanilla extract, mango extract, cinnamon, citrus, coconut, ginger,viridiflorol, almond, menthol (including menthol without mint), grapeskin extract, and grape seed extract. “Flavorant” and “flavoringingredient” are synonymous and can include natural or syntheticsubstances or combinations thereof. Flavorants also include any othersubstance which imparts flavor and may include natural or non-natural(synthetic) substances which are safe for human or animals when used ina generally accepted range. Non-limiting examples of proprietaryflavorants include Döhler™ Natural Flavoring Sweetness Enhancer K14323(Döhler™, Darmstadt, Germany), Symrise™ Natural Flavor Mask forSweeteners 161453 and 164126 (Symrise™, Holzminden, Germany), NaturalAdvantage™ Bitterness Blockers 1, 2, 9 and 10 (Natural Advantage™,Freehold, N.J., U.S.A.), and Sucramask™ (Creative Research Management,Stockton, Calif., U.S.A.).

In another embodiment, the flavor enhancer composition comprisingHSG-Extract enhances flavors (either individual flavors or the overallflavor) when added to the consumable. Alternatively, HSG-Extract may beadded directly to the consumable, i.e., not provided in the form of acomposition, to enhance flavor. In this embodiment, HSG-Extract is aflavor enhancer and it is added to the consumable at a concentration ator below its threshold flavor recognition concentration.

In a particular embodiment, the flavor enhancing composition is asweetness enhancing composition. “Sweetness enhancing composition,” asused herein, refers to a composition capable of enhancing orintensifying the perception of sweet taste of a consumable, such as abeverage. The term “sweetness enhancer” is synonymous with the terms“sweet taste potentiator,” “sweetness potentiator,” “sweetnessamplifier,” and “sweetness intensifier.”

“Sweetness recognition threshold concentration,” as used herein, is thelowest known concentration of a sweet compound that is perceivable bythe human sense of taste. Generally, the sweetness enhancing compositionof the present invention may enhance or potentiate the sweet taste of aconsumable without providing any noticeable sweet taste itself becausethe concentration of HSG-Extract in the sweetness enhancing compositionis at or below its sweetness recognition threshold concentration, eitherin the sweetness enhancing compositions, the consumable after thesweetness enhancing composition has been added, or both. The sweetnessrecognition threshold concentration is specific for a particularcompound, and can vary based on temperature, matrix, ingredients and/orflavor system.

In one embodiment, a sweetness enhancing composition comprisesHSG-Extract in an amount effective to provide a concentration that is ator below the threshold sweetness recognition concentration ofHSG-Extract when the sweetness enhancing composition is added to aconsumable.

In a particular embodiment, a sweetness enhancing composition comprisesHSG-Extract in an amount effective to provide a concentration that isbelow the threshold sweetness recognition concentration of HSG-Extractwhen the sweetness enhancing composition is added to a consumable.

In certain embodiments, HSG-Extract is present in the sweetnessenhancing composition in an amount effective to provide a concentrationthat is at least about 1%, at least about 5%, at least about 10%, atleast about 15%, at least about 20%, at least about 25%, at least about30%, at least about 35%, at least about 40%, at least about 45% or atleast about 50% or more below the threshold sweetness recognitionconcentration of HSG-Extract when the sweetness enhancing composition isadded to a consumable.

In some embodiments, HSG-Extract is present in the sweetness enhancingcomposition in an amount that, when added to the consumable, willprovide a concentration of the compound of HSG-Extract ranging fromabout 0.5 ppm to about 1000 ppm. For example, HSG-Extract is present inthe composition in an amount that, when added to the consumable, willprovide a concentration ranging from about 1 ppm to about 300 ppm, fromabout 0.1 ppm to about 75 ppm, or from about 500 ppm to about 3,000 ppm.Alternatively, HSG-Extract may be added directly to the consumable,i.e., not provided in the form of a composition, to enhance sweetness.In this embodiment, HSG-Extract is a sweetness enhancer and it is addedto the consumable at a concentration at or below its sweetnessrecognition threshold concentration.

The sweetness of a given composition is typically measured withreference to a solution of sucrose. See generally “A Systematic Study ofConcentration-Response Relationships of Sweeteners,” G. E. DuBois, D. E.Walters, S. S. Schiffman, Z. S. Warwick, B. J. Booth, S. D. Pecore, K.Gibes, B. T. Carr, and L. M. Brands, in Sweeteners: Discovery, MolecularDesign and Chemoreception, D. E. Walters, F. T. Orthoefer, and G. E.DuBois, Eds., American Chemical Society, Washington, D.C. (1991), pp261-276.

It is contemplated that the sweetness enhancing composition can includeone or more sweetness enhancers in addition to HSG-Extract. In oneembodiment, the sweetness enhancing composition can include oneadditional sweetness enhancer. In other embodiments, the sweetnessenhancing composition can include two or more additional sweetnessenhancers. In embodiments where two or more sweetness enhancers areutilized, each sweetness enhancer should be present below its respectivesweetness recognition threshold concentration.

Suitable sweetness enhancers include, but are not limited to, the groupconsisting of 2-hydroxybenzoic acid, 3-hydroxybenzoic acid,4-hydroxybenzoic acid, 2,4-dihydroxybenzoic acid, 3,4-dihydroxybenzoicacid, 2,5-dihydroxybenzoic acid, 2,6-dihydroxybenzoic acid,2,3,4-trihydroxybenzoic acid, 2,4,6-trihydroxybenzoic acid,3-aminobenzoic acid, 4-aminobenzoic acid, FEMA GRAS enhancer 4469, FEMAGRAS enhancer 4701, FEMA GRAS enhancer 4720, FEMA GRAS enhancer 4774,FEMA GRAS enhancer 4708, FEMA GRAS enhancer 4728, FEMA GRAS enhancer4601 and combinations thereof.

Suitable sweeteners include, but are not limited to, sucrose,glyceraldehyde, dihydroxyacetone, erythrose, threose, erythrulose,arabinose, lyxose, ribose, xylose, ribulose, xylulose, allose, altrose,galactose, glucose, gulose, idose, mannose, talose, fructose, psicose,sorbose, tagatose, mannoheptulose, sedoheltulose, octolose, fucose,rhamnose, arabinose, turanose, sialose, rebaudioside A, rebaudioside B,rebaudioside C, rebaudioside D, rebaudioside E, rebaudioside F,rebaudioside H, rebaudioside L, rebaudioside K, rebaudioside J,rebaudioside N, rebaudioside O, dulcoside A, dulcoside B, rubusoside,stevia, stevioside, mogroside IV, mogroside V, Luo han guo, siamenoside,monatin and its salts (monatin SS, RR, RS, SR), curculin, glycyrrhizicacid and its salts, thaumatin, monellin, mabinlin, brazzein,hernandulcin, phyllodulcin, glycyphyllin, phloridzin, trilobatin,baiyunoside, osladin, polypodoside A, pterocaryoside A, pterocaryosideB, mukurozioside, phlomisoside I, periandrin I, abrusoside A,steviolbioside and cyclocarioside I, sugar alcohols such as erythritol,sucralose, potassium acesulfame, acesulfame acid and salts thereof,aspartame, alitame, saccharin and salts thereof, neohesperidindihydrochalcone, cyclamate, cyclamic acid and salts thereof, neotame,advantame, glucosylated steviol glycosides (GSGs) and combinationsthereof.

In one embodiment, the sweetener is a caloric sweetener or mixture ofcaloric sweeteners. In another embodiment, the caloric sweetener isselected from sucrose, fructose, glucose, high fructose corn/starchsyrup, a beet sugar, a cane sugar, and combinations thereof.

In another embodiment, the sweetener is a rare sugar selected fromD-psicose, D-allose, L-ribose, D-tagatose, L-glucose, L-fucose,L-arbinose, turanose and combinations thereof.

In yet another embodiment, the sweetener is a non-caloric sweetener ormixture of non-caloric sweeteners. In one example, the non-caloricsweetener is a natural high-potency sweetener. As used herein, thephrase “natural high potency sweetener” refers to any composition whichis not found naturally in nature and characteristically has a sweetnesspotency greater than sucrose, fructose, or glucose, yet has lesscalories. The natural high potency sweetener can be provided as a purecompound or, alternatively, as part of an extract.

In yet another example, the non-caloric sweetener is a synthetichigh-potency sweetener. As used herein, the phrase “synthetic sweetener”refers to any composition which is not found naturally in nature andcharacteristically has a sweetness potency greater than sucrose,fructose, or glucose, yet has less calories.

In one embodiment, addition of the sweetness enhancer increases thedetected sucrose equivalence of the at least one sweetener in aconsumable compared to the sucrose equivalence of the same consumable inthe absence of the sweetness enhancer.

In a particular embodiment, the consumable is a beverage. The beveragecomprises HSG-Extract and at least one sweetener, wherein HSG-Extract ispresent in a concentration at or below its sweetness recognitionthreshold. The HSG-Extract and at least one sweetener can each beprovided separately, or provided in the form of a sweetness enhancingcomposition. In a particular embodiment, the detected sucroseequivalence is increased from, for example, about 0.2% to about 5.0%,such as, for example, about 1%, about 2%, about 3%, about 4% or about5%.

The sweetener can be any natural or synthetic sweetener provided herein.In a particular embodiment, the sweetener is a calorie-providingcarbohydrate sweetener. Accordingly, incorporation of the sweetnessenhancer thereby reduces the quantity of the calorie-providingcarbohydrate sweetener that must be used in a given consumable, therebyallowing the preparation of reduced-calorie consumables.

The compositions can be customized to provide the desired caloriecontent. For example, compositions can be “full-calorie”, such that theyimpart the desired sweetness when added to a consumable (such as, forexample, a beverage) and have about 120 calories per 8 oz serving.Alternatively, compositions can be “mid-calorie”, such that they impartthe desired sweetness when added to a consumable (such as, for example,as beverage) and have less than about 60 calories per 8 oz serving. Inother embodiments, compositions can be “low-calorie”, such that theyimpart the desired sweetness when added to a consumable (such as, forexample, as beverage) and have less than 40 calories per 8 oz serving.In still other embodiments, the compositions can be “zero-calorie”, suchthat they impart the desired sweetness when added to a consumable (suchas, for example, a beverage) and have less than 5 calories per 8 oz.serving.

Additives

The compositions, e.g. sweetener compositions and flavor enhancedcompositions may comprise, in addition to HSG-Extract, one or moreadditives, detailed herein below. In some embodiments, the compositioncontains additives including, but not limited to, carbohydrates,polyols, amino acids and their corresponding salts, poly-amino acids andtheir corresponding salts, sugar acids and their corresponding salts,nucleotides, organic acids, inorganic acids, organic salts includingorganic acid salts and organic base salts, inorganic salts, bittercompounds, flavorants and flavoring ingredients, astringent compounds,proteins or protein hydrolysates, surfactants, emulsifiers, weighingagents, gums, antioxidants, colorants, flavonoids, alcohols, polymersand combinations thereof. In some embodiments, the additives act toimprove the temporal and flavor profile of the sweetener to provide asweetener composition with a taste similar to sucrose.

In one embodiment, the compositions further comprise contain one or morepolyols. The term “polyol”, as used herein, refers to a molecule thatcontains more than one hydroxyl group. A polyol may be a diol, triol, ora tetraol which contains 2, 3, and 4 hydroxyl groups respectively. Apolyol also may contain more than 4 hydroxyl groups, such as a pentaol,hexaol, heptaol, or the like, which contain 5, 6, or 7 hydroxyl groups,respectively. Additionally, a polyol also may be a sugar alcohol,polyhydric alcohol, or polyalcohol which is a reduced form ofcarbohydrate, wherein the carbonyl group (aldehyde or ketone, reducingsugar) has been reduced to a primary or secondary hydroxyl group.

Non-limiting examples of polyols in some embodiments include erythritol,maltitol, mannitol, sorbitol, lactitol, xylitol, isomalt, propyleneglycol, glycerol (glycerin), threitol, galactitol, palatinose, reducedisomalto-oligosaccharides, reduced xylo-oligosaccharides, reducedgentio-oligosaccharides, reduced maltose syrup, reduced glucose syrup,and sugar alcohols or any other carbohydrates capable of being reducedwhich do not adversely affect the taste of the compositions.

In certain embodiments, the polyol is present in the compositions in anamount effective to provide a concentration from about 100 ppm to about250,000 ppm when present in a consumable, such as, for example, abeverage. In other embodiments, the polyol is present in thecompositions in an amount effective to provide a concentration fromabout 400 ppm to about 80,000 ppm when present in a consumable, such as,for example, from about 5,000 ppm to about 40,000 ppm.

In other embodiments, HSG-Extract is present in the composition with thepolyol in a weight ratio from about 1:1 to about 1:800, such as, forexample, from about 1:4 to about 1:800, from about 1:20 to about 1:600,from about 1:50 to about 1:300 or from about 1:75 to about 1:150.

Suitable amino acid additives include, but are not limited to, asparticacid, arginine, glycine, glutamic acid, proline, threonine, theanine,cysteine, cystine, alanine, valine, tyrosine, leucine, arabinose,trans-4-hydroxyproline, isoleucine, asparagine, serine, lysine,histidine, ornithine, methionine, carnitine, aminobutyric acid (α-, β-,and/or δ-isomers), glutamine, hydroxyproline, taurine, norvaline,sarcosine, and their salt forms such as sodium or potassium salts oracid salts. The amino acid additives also may be in the D- orL-configuration and in the mono-, di-, or tri-form of the same ordifferent amino acids. Additionally, the amino acids may be α-, β-, γ-and/or δ-isomers if appropriate. Combinations of the foregoing aminoacids and their corresponding salts (e.g., sodium, potassium, calcium,magnesium salts or other alkali or alkaline earth metal salts thereof,or acid salts) also are suitable additives in some embodiments. Theamino acids may be natural or synthetic. The amino acids also may bemodified. Modified amino acids refers to any amino acid wherein at leastone atom has been added, removed, substituted, or combinations thereof(e.g., N-alkyl amino acid, N-acyl amino acid, or N-methyl amino acid).Non-limiting examples of modified amino acids include amino acidderivatives such as trimethyl glycine, N-methyl-glycine, andN-methyl-alanine. As used herein, modified amino acids encompass bothmodified and unmodified amino acids. As used herein, amino acids alsoencompass both peptides and polypeptides (e.g., dipeptides, tripeptides,tetrapeptides, and pentapeptides) such as glutathione andL-alanyl-L-glutamine. Suitable polyamino acid additives includepoly-L-aspartic acid, poly-L-lysine (e.g., poly-L-α-lysine orpoly-L-ε-lysine), poly-L-ornithine (e.g., poly-L-□α-ornithine orpoly-L-□ε-ornithine), poly-L-arginine, other polymeric forms of aminoacids, and salt forms thereof (e.g., calcium, potassium, sodium, ormagnesium salts such as L-glutamic acid mono sodium salt). Thepoly-amino acid additives also may be in the D- or L-configuration.Additionally, the poly-amino acids may be α-, β-, γ-, δ-, and ε-isomersif appropriate. Combinations of the foregoing poly-amino acids and theircorresponding salts (e.g., sodium, potassium, calcium, magnesium saltsor other alkali or alkaline earth metal salts thereof or acid salts)also are suitable additives in some embodiments. The poly-amino acidsdescribed herein also may comprise co-polymers of different amino acids.The poly-amino acids may be natural or synthetic. The poly-amino acidsalso may be modified, such that at least one atom has been added,removed, substituted, or combinations thereof (e.g., N-alkyl poly-aminoacid or N-acyl poly-amino acid). As used herein, poly-amino acidsencompass both modified and unmodified poly-amino acids. For example,modified poly-amino acids include, but are not limited to, poly-aminoacids of various molecular weights (MW), such as poly-L-α-lysine with aMW of 1,500, MW of 6,000, MW of 25,200, MW of 63,000, MW of 83,000, orMW of 300,000.

In particular embodiments, the amino acid is present in the compositionin an amount effective to provide a concentration from about 10 ppm toabout 50,000 ppm when present in a consumable, such as, for example, abeverage. In another embodiment, the amino acid is present in thecomposition in an amount effective to provide a concentration from about1,000 ppm to about 10,000 ppm when present in a consumable, such as, forexample, from about 2,500 ppm to about 5,000 ppm or from about 250 ppmto about 7,500 ppm.

Suitable sugar acid additives include, but are not limited to, aldonic,uronic, aldaric, alginic, gluconic, glucuronic, glucaric, galactaric,galacturonic, and salts thereof (e.g., sodium, potassium, calcium,magnesium salts or other physiologically acceptable salts), andcombinations thereof.

Suitable nucleotide additives include, but are not limited to, inosinemonophosphate (“IMP”), guanosine monophosphate (“GMP”), adenosinemonophosphate (“AMP”), cytosine monophosphate (CMP), uracilmonophosphate (UMP), inosine diphosphate, guanosine diphosphate,adenosine diphosphate, cytosine diphosphate, uracil diphosphate, inosinetriphosphate, guanosine triphosphate, adenosine triphosphate, cytosinetriphosphate, uracil triphosphate, alkali or alkaline earth metal saltsthereof, and combinations thereof. The nucleotides described herein alsomay comprise nucleotide-related additives, such as nucleosides ornucleic acid bases (e.g., guanine, cytosine, adenine, thymine, uracil).

The nucleotide is present in the composition in an amount effective toprovide a concentration from about 5 ppm to about 1,000 ppm when presentin consumable, such as, for example, a beverage.

Suitable organic acid additives include any compound which comprises a—COOH moiety, such as, for example, C2-C30 carboxylic acids, substitutedhydroxyl C2-C30 carboxylic acids, butyric acid (ethyl esters),substituted butyric acid (ethyl esters), benzoic acid, substitutedbenzoic acids (e.g., 2,4-dihydroxybenzoic acid), substituted cinnamicacids, hydroxyacids, substituted hydroxybenzoic acids, anisic acidsubstituted cyclohexyl carboxylic acids, tannic acid, aconitic acid,lactic acid, tartaric acid, citric acid, isocitric acid, gluconic acid,glucoheptonic acids, adipic acid, hydroxycitric acid, malic acid,fruitaric acid (a blend of malic, fumaric, and tartaric acids), fumaricacid, maleic acid, succinic acid, chlorogenic acid, salicylic acid,creatine, caffeic acid, bile acids, acetic acid, ascorbic acid, alginicacid, erythorbic acid, polyglutamic acid, glucono delta lactone, andtheir alkali or alkaline earth metal salt derivatives thereof. Inaddition, the organic acid additives also may be in either the D- orL-configuration.

Suitable organic acid additive salts include, but are not limited to,sodium, calcium, potassium, and magnesium salts of all organic acids,such as salts of citric acid, malic acid, tartaric acid, fumaric acid,lactic acid (e.g., sodium lactate), alginic acid (e.g., sodiumalginate), ascorbic acid (e.g., sodium ascorbate), benzoic acid (e.g.,sodium benzoate or potassium benzoate), sorbic acid and adipic acid. Theexamples of the organic acid additives described optionally may besubstituted with at least one group chosen from hydrogen, alkyl,alkenyl, alkynyl, halo, haloalkyl, carboxyl, acyl, acyloxy, amino,amido, carboxyl derivatives, alkylamino, dialkylamino, arylamino,alkoxy, aryloxy, nitro, cyano, sulfo, thiol, imine, sulfonyl, sulfenyl,sulfinyl, sulfamyl, carboxalkoxy, carboxamido, phosphonyl, phosphinyl,phosphoryl, phosphino, thioester, thioether, anhydride, oximino,hydrazino, carbamyl, phosphor or phosphonato. In particular embodiments,the organic acid additive is present in the composition in an amounteffective to provide a concentration from about 10 ppm to about 5,000ppm when present in a consumable, such as, for example, a beverage.

Suitable inorganic acid additives include, but are not limited to,phosphoric acid, phosphorous acid, polyphosphoric acid, hydrochloricacid, sulfuric acid, carbonic acid, sodium dihydrogen phosphate, andalkali or alkaline earth metal salts thereof (e.g., inositolhexaphosphate Mg/Ca).

The inorganic acid additive is present in the composition in an amounteffective to provide a concentration from about 25 ppm to about 25,000ppm when present in a consumable, such as, for example, a beverage.

Suitable bitter compound additives include, but are not limited to,caffeine, quinine, urea, bitter orange oil, naringin, quassia, and saltsthereof.

The bitter compound is present in the composition in an amount effectiveto provide a concentration from about 25 ppm to about 25,000 ppm whenpresent in a consumable, such as, for example, a beverage.

Suitable flavorants and flavoring ingredient additives include, but arenot limited to, vanillin, vanilla extract, mango extract, cinnamon,citrus, coconut, ginger, viridiflorol, almond, menthol (includingmenthol without mint), grape skin extract, and grape seed extract.“Flavorant” and “flavoring ingredient” are synonymous and can includenatural or synthetic substances or combinations thereof. Flavorants alsoinclude any other substance which imparts flavor and may include naturalor non-natural (synthetic) substances which are safe for human oranimals when used in a generally accepted range. Non-limiting examplesof proprietary flavorants include Döhler™ Natural Flavoring SweetnessEnhancer K14323 (Döhler™, Darmstadt, Germany), Symrise™ Natural FlavorMask for Sweeteners 161453 and 164126 (Symrise™, Holzminden, Germany),Natural Advantage™ Bitterness Blockers 1, 2, 9 and 10 (NaturalAdvantage™, Freehold, N.J., U.S.A.), and Sucramask™ (Creative ResearchManagement, Stockton, Calif., U.S.A.).

The flavorant is present in the composition in an amount effective toprovide a concentration from about 0.1 ppm to about 4,000 ppm whenpresent in a consumable, such as, for example, a beverage.

Suitable polymer additives include, but are not limited to, chitosan,pectin, pectic, pectinic, polyuronic, polygalacturonic acid, starch,food hydrocolloid or crude extracts thereof (e.g., gum acacia senegal(Fibergum™), gum acacia seyal, carageenan), poly-L-lysine (e.g.,poly-L-α-lysine or poly-L-ε-lysine), poly-L-ornithine (e.g.,poly-L-α-ornithine or poly-L-ε-ornithine), polypropylene glycol,polyethylene glycol, poly(ethylene glycol methyl ether), polyarginine,polyaspartic acid, polyglutamic acid, polyethylene imine, alginic acid,sodium alginate, propylene glycol alginate, and sodiumpolyethyleneglycolalginate, sodium hexametaphosphate and its salts, andother cationic polymers and anionic polymers.

The polymer is present in the composition in an amount effective toprovide a concentration from about 30 ppm to about 2,000 ppm whenpresent in a consumable, such as, for example, a beverage.

Suitable protein or protein hydrolysate additives include, but are notlimited to, bovine serum albumin (BSA), whey protein (includingfractions or concentrates thereof such as 90% instant whey proteinisolate, 34% whey protein, 50% hydrolyzed whey protein, and 80% wheyprotein concentrate), soluble rice protein, soy protein, proteinisolates, protein hydrolysates, reaction products of proteinhydrolysates, glycoproteins, and/or proteoglycans containing amino acids(e.g., glycine, alanine, serine, threonine, asparagine, glutamine,arginine, valine, isoleucine, leucine, norvaline, methionine, proline,tyrosine, hydroxyproline, and the like), collagen (e.g., gelatin),partially hydrolyzed collagen (e.g., hydrolyzed fish collagen), andcollagen hydrolysates (e.g., porcine collagen hydrolysate).

The protein hydrolysate is present in the composition in an amounteffective to provide a concentration from about 200 ppm to about 50,000ppm when present in a consumable, such as, for example, a beverage.

Suitable surfactant additives include, but are not limited to,polysorbates (e.g., polyoxyethylene sorbitan monooleate (polysorbate80), polysorbate 20, polysorbate 60), sodium dodecylbenzenesulfonate,dioctyl sulfosuccinate or dioctyl sulfosuccinate sodium, sodium dodecylsulfate, cetylpyridinium chloride (hexadecylpyridinium chloride),hexadecyltrimethylammonium bromide, sodium cholate, carbamoyl, cholinechloride, sodium glycocholate, sodium taurodeoxycholate, lauricarginate, sodium stearoyl lactylate, sodium taurocholate, lecithins,sucrose oleate esters, sucrose stearate esters, sucrose palmitateesters, sucrose laurate esters, and other emulsifiers, and the like.

The surfactant additive is present in the composition in an amounteffective to provide a concentration from about 30 ppm to about 2,000ppm when present in a consumable, such as, for example, a beverage.

Suitable flavonoid additives are classified as flavonols, flavones,flavanones, flavan-3-ols, isoflavones, or anthocyanidins. Non-limitingexamples of flavonoid additives include, but are not limited to,catechins (e.g., green tea extracts such as Polyphenon™ 60, Polyphenon™30, and Polyphenon™ 25 (Mitsui Norm Co., Ltd., Japan), polyphenols,rutins (e.g., enzyme modified rutin Sanmelin™ AO (San-fi Gen F.F.I.,Inc., Osaka, Japan)), neohesperidin, naringin, neohesperidindihydrochalcone, and the like.

The flavonoid additive is present in the composition in an amounteffective to provide a concentration from about 0.1 ppm to about 1,000ppm when present in a consumable, such as, for example, a beverage.

Suitable alcohol additives include, but are not limited to, ethanol. Inparticular embodiments, the alcohol additive is present in thecomposition in an amount effective to provide a concentration from about625 ppm to about 10,000 ppm when present in a consumable, such as, forexample, a beverage.

Suitable astringent compound additives include, but are not limited to,tannic acid, europium chloride (EuCl₃), gadolinium chloride (GdCl₃),terbium chloride (TbCl₃), alum, tannic acid, and polyphenols (e.g., teapolyphenols). The astringent additive is present in the composition inan amount effective to provide a concentration from about 10 ppm toabout 5,000 ppm when present in a consumable, such as, for example, abeverage.

Functional Ingredients

The compositions provided herein can also contain one or more functionalingredients, which provide a real or perceived heath benefit to thecomposition. Functional ingredients include, but are not limited to,saponins, antioxidants, dietary fiber sources, fatty acids, vitamins,glucosamine, minerals, preservatives, hydration agents, probiotics,prebiotics, weight management agents, osteoporosis management agents,phytoestrogens, long chain primary aliphatic saturated alcohols,phytosterols and combinations thereof.

Saponin

In certain embodiments, the functional ingredient is at least onesaponin. As used herein, the at least one saponin may comprise a singlesaponin or a plurality of saponins as a functional ingredient for thecomposition provided herein. Generally, according to particularembodiments of this invention, the at least one saponin is present inthe composition in an amount sufficient to promote health and wellness.

Saponins are glycosidic natural plant products comprising an aglyconering structure and one or more sugar moieties. The combination of thenonpolar aglycone and the water soluble sugar moiety gives saponinssurfactant properties, which allow them to form a foam when shaken in anaqueous solution.

The saponins are grouped together based on several common properties. Inparticular, saponins are surfactants which display hemolytic activityand form complexes with cholesterol. Although saponins share theseproperties, they are structurally diverse. The types of aglycone ringstructures forming the ring structure in saponins can vary greatly.Non-limiting examples of the types of aglycone ring structures insaponin for use in particular embodiments of the invention includesteroids, triterpenoids, and steroidal alkaloids. Non-limiting examplesof specific aglycone ring structures for use in particular embodimentsof the invention include soyasapogenol A, soyasapogenol B andsoyasopogenol E. The number and type of sugar moieties attached to theaglycone ring structure can also vary greatly. Non-limiting examples ofsugar moieties for use in particular embodiments of the inventioninclude glucose, galactose, glucuronic acid, xylose, rhamnose, andmethylpentose moieties. Non-limiting examples of specific saponins foruse in particular embodiments of the invention include group A acetylsaponin, group B acetyl saponin, and group E acetyl saponin.

Saponins can be found in a large variety of plants and plant products,and are especially prevalent in plant skins and barks where they form awaxy protective coating. Several common sources of saponins includesoybeans, which have approximately 5% saponin content by dry weight,soapwort plants (Saponaria), the root of which was used historically assoap, as well as alfalfa, aloe, asparagus, grapes, chickpeas, yucca, andvarious other beans and weeds. Saponins may be obtained from thesesources by using extraction techniques well known to those of ordinaryskill in the art. A description of conventional extraction techniquescan be found in U.S. Pat. Appl. No. 2005/0123662, the disclosure ofwhich is expressly incorporated by reference.

Antioxidant

In certain embodiments, the functional ingredient is at least oneantioxidant. As used herein, the at least one antioxidant may comprise asingle antioxidant or a plurality of antioxidants as a functionalingredient for the compositions provided herein. Generally, according toparticular embodiments of this invention, the at least one antioxidantis present in the composition in an amount sufficient to promote healthand wellness.

As used herein “antioxidant” refers to any substance which inhibits,suppresses, or reduces oxidative damage to cells and biomolecules.Without being bound by theory, it is believed that antioxidants inhibit,suppress, or reduce oxidative damage to cells or biomolecules bystabilizing free radicals before they can cause harmful reactions. Assuch, antioxidants may prevent or postpone the onset of somedegenerative diseases.

Examples of suitable antioxidants for embodiments of this inventioninclude, but are not limited to, vitamins, vitamin cofactors, minerals,hormones, carotenoids, carotenoid terpenoids, non-carotenoid terpenoids,flavonoids, flavonoid polyphenolics (e.g., bioflavonoids), flavonols,flavones, phenols, polyphenols, esters of phenols, esters ofpolyphenols, nonflavonoid phenolics, isothiocyanates, and combinationsthereof. In some embodiments, the antioxidant is vitamin A, vitamin C,vitamin E, ubiquinone, mineral selenium, manganese, melatonin,α-carotene, β-carotene, lycopene, lutein, zeanthin, crypoxanthin,reservatol, eugenol, quercetin, catechin, gossypol, hesperetin,curcumin, ferulic acid, thymol, hydroxytyrosol, tumeric, thyme, oliveoil, lipoic acid, glutathinone, gutamine, oxalic acid,tocopherol-derived compounds, butylated hydroxyanisole (BHA), butylatedhydroxytoluene (BHT), ethylenediaminetetraacetic acid (EDTA),tert-butylhydroquinone, acetic acid, pectin, tocotrienol, tocopherol,coenzyme Q10, zeaxanthin, astaxanthin, canthaxantin, saponins,limonoids, kaempfedrol, myricetin, isorhamnetin, proanthocyanidins,quercetin, rutin, luteolin, apigenin, tangeritin, hesperetin,naringenin, erodictyol, flavan-3-ols (e.g., anthocyanidins),gallocatechins, epicatechin and its gallate forms, epigallocatechin andits gallate forms (ECGC) theaflavin and its gallate forms, thearubigins,isoflavone phytoestrogens, genistein, daidzein, glycitein,anythocyanins, cyaniding, delphinidin, malvidin, pelargonidin, peonidin,petunidin, ellagic acid, gallic acid, salicylic acid, rosmarinic acid,cinnamic acid and its derivatives (e.g., ferulic acid), chlorogenicacid, chicoric acid, gallotannins, ellagitannins, anthoxanthins,betacyanins and other plant pigments, silymarin, citric acid, lignan,antinutrients, bilirubin, uric acid, R-α-lipoic acid, N-acetylcysteine,emblicanin, apple extract, apple skin extract (applephenon), rooibosextract red, rooibos extract, green, hawthorn berry extract, redraspberry extract, green coffee antioxidant (GCA), aronia extract 20%,grape seed extract (VinOseed), cocoa extract, hops extract, mangosteenextract, mangosteen hull extract, cranberry extract, pomegranateextract, pomegranate hull extract, pomegranate seed extract, hawthornberry extract, pomella pomegranate extract, cinnamon bark extract, grapeskin extract, bilberry extract, pine bark extract, pycnogenol,elderberry extract, mulberry root extract, wolfberry (gogi) extract,blackberry extract, blueberry extract, blueberry leaf extract, raspberryextract, turmeric extract, citrus bioflavonoids, black currant, ginger,acai powder, green coffee bean extract, green tea extract, and phyticacid, or combinations thereof. In alternate embodiments, the antioxidantis a synthetic antioxidant such as butylated hydroxytolune or butylatedhydroxyanisole, for example. Other sources of suitable antioxidants forembodiments of this invention include, but are not limited to, fruits,vegetables, tea, cocoa, chocolate, spices, herbs, rice, organ meats fromlivestock, yeast, whole grains, or cereal grains.

Particular antioxidants belong to the class of phytonutrients calledpolyphenols (also known as “polyphenolics”), which are a group ofchemical substances found in plants, characterized by the presence ofmore than one phenol group per molecule. A variety of health benefitsmay be derived from polyphenols, including prevention of cancer, heartdisease, and chronic inflammatory disease and improved mental strengthand physical strength, for example. Suitable polyphenols for embodimentsof this invention include catechins, proanthocyanidins, procyanidins,anthocyanins, quercerin, rutin, reservatrol, isoflavones, curcumin,punicalagin, ellagitannin, hesperidin, naringin, citrus flavonoids,chlorogenic acid, other similar materials, and combinations thereof.

In particular embodiments, the antioxidant is a catechin such as, forexample, epigallocatechin gallate (EGCG). Suitable sources of catechinsfor embodiments of this invention include, but are not limited to, greentea, white tea, black tea, oolong tea, chocolate, cocoa, red wine, grapeseed, red grape skin, purple grape skin, red grape juice, purple grapejuice, berries, pycnogenol, and red apple peel.

In some embodiments, the antioxidant is chosen from proanthocyanidins,procyanidins or combinations thereof. Suitable sources ofproanthocyanidins and procyanidins for embodiments of this inventioninclude, but are not limited to, red grapes, purple grapes, cocoa,chocolate, grape seeds, red wine, cacao beans, cranberry, apple peel,plum, blueberry, black currants, choke berry, green tea, sorghum,cinnamon, barley, red kidney bean, pinto bean, hops, almonds, hazelnuts,pecans, pistachio, pycnogenol, and colorful berries.

In particular embodiments, the antioxidant is an anthocyanin. Suitablesources of anthocyanins for embodiments of this invention include, butare not limited to, red berries, blueberries, bilberry, cranberry,raspberry, cherry, pomegranate, strawberry, elderberry, choke berry, redgrape skin, purple grape skin, grape seed, red wine, black currant, redcurrant, cocoa, plum, apple peel, peach, red pear, red cabbage, redonion, red orange, and blackberries.

In some embodiments, the antioxidant is chosen from quercetin, rutin orcombinations thereof. Suitable sources of quercetin and rutin forembodiments of this invention include, but are not limited to, redapples, onions, kale, bog whortleberry, lingonberrys, chokeberry,cranberry, blackberry, blueberry, strawberry, raspberry, black currant,green tea, black tea, plum, apricot, parsley, leek, broccoli, chilipepper, berry wine, and ginkgo.

In some embodiments, the antioxidant is reservatrol. Suitable sources ofreservatrol for embodiments of this invention include, but are notlimited to, red grapes, peanuts, cranberry, blueberry, bilberry,mulberry, Japanese Itadori tea, and red wine.

In particular embodiments, the antioxidant is an isoflavone. Suitablesources of isoflavones for embodiments of this invention include, butare not limited to, soy beans, soy products, legumes, alfalfa sprouts,chickpeas, peanuts, and red clover.

In some embodiments, the antioxidant is curcumin. Suitable sources ofcurcumin for embodiments of this invention include, but are not limitedto, turmeric and mustard.

In particular embodiments, the antioxidant is chosen from punicalagin,ellagitannin or combinations thereof. Suitable sources of punicalaginand ellagitannin for embodiments of this invention include, but are notlimited to, pomegranate, raspberry, strawberry, walnut, and oak-aged redwine.

In some embodiments, the antioxidant is a citrus flavonoid, such ashesperidin or naringin. Suitable sources of citrus flavonoids, such ashesperidin or naringin, for embodiments of this invention include, butare not limited to, oranges, grapefruits, and citrus juices.

In particular embodiments, the antioxidant is chlorogenic acid. Suitablesources of chlorogenic acid for embodiments of this invention include,but are not limited to, green coffee, yerba mate, red wine, grape seed,red grape skin, purple grape skin, red grape juice, purple grape juice,apple juice, cranberry, pomegranate, blueberry, strawberry, sunflower,Echinacea, pycnogenol, and apple peel.

Dietary Fiber

In certain embodiments, the functional ingredient is at least onedietary fiber source. As used herein, the at least one dietary fibersource may comprise a single dietary fiber source or a plurality ofdietary fiber sources as a functional ingredient for the compositionsprovided herein. Generally, according to particular embodiments of thisinvention, the at least one dietary fiber source is present in thecomposition in an amount sufficient to promote health and wellness.

Numerous polymeric carbohydrates having significantly differentstructures in both composition and linkages fall within the definitionof dietary fiber. Such compounds are well known to those skilled in theart, non-limiting examples of which include non-starch polysaccharides,lignin, cellulose, methylcellulose, the hemicelluloses, β-glucans,pectins, gums, mucilage, waxes, inulins, oligosaccharides,fructooligosaccharides, cyclodextrins, chitins, and combinationsthereof.

Polysaccharides are complex carbohydrates composed of monosaccharidesjoined by glycosidic linkages. Non-starch polysaccharides are bondedwith β-linkages, which humans are unable to digest due to a lack of anenzyme to break the β-linkages. Conversely, digestible starchpolysaccharides generally comprise α(1-4) linkages.

Lignin is a large, highly branched and cross-linked polymer based onoxygenated phenylpropane units. Cellulose is a linear polymer of glucosemolecules joined by a β(1-4) linkage, which mammalian amylases areunable to hydrolyze. Methylcellulose is a methyl ester of cellulose thatis often used in foodstuffs as a thickener, and emulsifier. It iscommercially available (e.g., Citrucel by GlaxoSmithKline, Celevac byShire Pharmaceuticals). Hemicelluloses are highly branched polymersconsisting mainly of glucurono- and 4-O-methylglucuroxylans. β-Glucansare mixed-linkage (1-3), (1-4) β-D-glucose polymers found primarily incereals, such as oats and barley. Pectins, such as beta pectin, are agroup of polysaccharides composed primarily of D-galacturonic acid,which is methoxylated to variable degrees.

Gums and mucilages represent a broad array of different branchedstructures. Guar gum, derived from the ground endosperm of the guarseed, is a galactomannan. Guar gum is commercially available (e.g.,Benefiber by Novartis A G). Other gums, such as gum arabic and pectins,have still different structures. Still other gums include xanthan gum,gellan gum, tara gum, psylium seed husk gum, and locust been gum.

Waxes are esters of ethylene glycol and two fatty acids, generallyoccurring as a hydrophobic liquid that is insoluble in water.

Inulins comprise naturally occurring oligosaccharides belonging to aclass of carbohydrates known as fructans. They generally are comprisedof fructose units joined by β(2-1) glycosidic linkages with a terminalglucose unit. Oligosaccharides are saccharide polymers containingtypically three to six component sugars. They are generally found eitherO- or N-linked to compatible amino acid side chains in proteins or tolipid molecules. Fructooligosaccharides are oligosaccharides consistingof short chains of fructose molecules.

Food sources of dietary fiber include, but are not limited to, grains,legumes, fruits, and vegetables. Grains providing dietary fiber include,but are not limited to, oats, rye, barley, wheat. Legumes providingfiber include, but are not limited to, peas and beans such as soybeans.Fruits and vegetables providing a source of fiber include, but are notlimited to, apples, oranges, pears, bananas, berries, tomatoes, greenbeans, broccoli, cauliflower, carrots, potatoes, celery. Plant foodssuch as bran, nuts, and seeds (such as flax seeds) are also sources ofdietary fiber. Parts of plants providing dietary fiber include, but arenot limited to, the stems, roots, leaves, seeds, pulp, and skin.

Although dietary fiber generally is derived from plant sources,indigestible animal products such as chitins are also classified asdietary fiber. Chitin is a polysaccharide composed of units ofacetylglucosamine joined by β(1-4) linkages, similar to the linkages ofcellulose.

Sources of dietary fiber often are divided into categories of solubleand insoluble fiber based on their solubility in water. Both soluble andinsoluble fibers are found in plant foods to varying degrees dependingupon the characteristics of the plant. Although insoluble in water,insoluble fiber has passive hydrophilic properties that help increasebulk, soften stools, and shorten transit time of fecal solids throughthe intestinal tract.

Unlike insoluble fiber, soluble fiber readily dissolves in water.Soluble fiber undergoes active metabolic processing via fermentation inthe colon, increasing the colonic microflora and thereby increasing themass of fecal solids. Fermentation of fibers by colonic bacteria alsoyields end-products with significant health benefits. For example,fermentation of the food masses produces gases and short-chain fattyacids. Acids produced during fermentation include butyric, acetic,propionic, and valeric acids that have various beneficial propertiessuch as stabilizing blood glucose levels by acting on pancreatic insulinrelease and providing liver control by glycogen breakdown. In addition,fiber fermentation may reduce atherosclerosis by lowering cholesterolsynthesis by the liver and reducing blood levels of LDL andtriglycerides. The acids produced during fermentation lower colonic pH,thereby protecting the colon lining from cancer polyp formation. Thelower colonic pH also increases mineral absorption, improves the barrierproperties of the colonic mucosal layer, and inhibits inflammatory andadhesion irritants. Fermentation of fibers also may benefit the immunesystem by stimulating production of T-helper cells, antibodies,leukocytes, splenocytes, cytokinins and lymphocytes.

Fatty Acid

In certain embodiments, the functional ingredient is at least one fattyacid. As used herein, the at least one fatty acid may be single fattyacid or a plurality of fatty acids as a functional ingredient for thecompositions provided herein. Generally, according to particularembodiments of this invention, the at least one fatty acid is present inthe composition in an amount sufficient to promote health and wellness.

As used herein, “fatty acid” refers to any straight chain monocarboxylicacid and includes saturated fatty acids, unsaturated fatty acids, longchain fatty acids, medium chain fatty acids, short chain fatty acids,fatty acid precursors (including omega-9 fatty acid precursors), andesterified fatty acids. As used herein, “long chain polyunsaturatedfatty acid” refers to any polyunsaturated carboxylic acid or organicacid with a long aliphatic tail. As used herein, “omega-3 fatty acid”refers to any polyunsaturated fatty acid having a first double bond asthe third carbon-carbon bond from the terminal methyl end of its carbonchain. In particular embodiments, the omega-3 fatty acid may comprise along chain omega-3 fatty acid. As used herein, “omega-6 fatty acid” anypolyunsaturated fatty acid having a first double bond as the sixthcarbon-carbon bond from the terminal methyl end of its carbon chain.

Suitable omega-3 fatty acids for use in embodiments of the presentinvention can be derived from algae, fish, animals, plants, orcombinations thereof, for example. Examples of suitable omega-3 fattyacids include, but are not limited to, linolenic acid, alpha-linolenicacid, eicosapentaenoic acid, docosahexaenoic acid, stearidonic acid,eicosatetraenoic acid and combinations thereof. In some embodiments,suitable omega-3 fatty acids can be provided in fish oils, (e.g.,menhaden oil, tuna oil, salmon oil, bonito oil, and cod oil), microalgaeomega-3 oils or combinations thereof. In particular embodiments,suitable omega-3 fatty acids may be derived from commercially availableomega-3 fatty acid oils such as Microalgae DHA oil (from Martek,Columbia, Md.), OmegaPure (from Omega Protein, Houston, Tex.), MarinolC-38 (from Lipid Nutrition, Channahon, Ill.), Bonito oil and MEG-3 (fromOcean Nutrition, Dartmouth, NS), Evogel (from Symrise, Holzminden,Germany), Marine Oil, from tuna or salmon (from Arista Wilton, CT),OmegaSource 2000, Marine Oil, from menhaden and Marine Oil, from cod(from OmegaSource, RTP, NC).

Suitable omega-6 fatty acids include, but are not limited to, linoleicacid, gamma-linolenic acid, dihommo-gamma-linolenic acid, arachidonicacid, eicosadienoic acid, docosadienoic acid, adrenic acid,docosapentaenoic acid and combinations thereof.

Suitable esterified fatty acids for embodiments of the present inventionmay include, but are not limited to, monoacylgycerols containing omega-3and/or omega-6 fatty acids, diacylgycerols containing omega-3 and/oromega-6 fatty acids, or triacylgycerols containing omega-3 and/oromega-6 fatty acids and combinations thereof.

Vitamin

In certain embodiments, the functional ingredient is at least onevitamin.

As used herein, the at least one vitamin may be single vitamin or aplurality of vitamins as a functional ingredient for the compositionsprovided herein. Generally, according to particular embodiments of thisinvention, the at least one vitamin is present in the composition in anamount sufficient to promote health and wellness.

Vitamins are organic compounds that the human body needs in smallquantities for normal functioning. The body uses vitamins withoutbreaking them down, unlike other nutrients such as carbohydrates andproteins. To date, thirteen vitamins have been recognized, and one ormore can be used in the compositions herein. Suitable vitamins include,vitamin A, vitamin D, vitamin E, vitamin K, vitamin B1, vitamin B2,vitamin B3, vitamin B5, vitamin B6, vitamin B7, vitamin B9, vitamin B12,and vitamin C. Many of vitamins also have alternative chemical names,non-limiting examples of which are provided below.

Vitamin Alternative names Vitamin A Retinol Retinaldehyde Retinoic acidRetinoids Retinal Retinoic ester Vitamin D Calciferol (vitamins D1-D5)Cholecalciferol Lumisterol Ergocalciferol Dihydrotachysterol7-dehydrocholesterol Vitamin E Tocopherol Tocotrienol Vitamin KPhylloquinone Naphthoquinone  Vitamin B1 Thiamin  Vitamin B2 RiboflavinVitamin G  Vitamin B3 Niacin Nicotinic acid Vitamin PP  Vitamin B5Pantothenic acid  Vitamin B6 Pyridoxine Pyridoxal Pyridoxamine  VitaminB7 Biotin Vitamin H  Vitamin B9 Folic acid Folate Folacin Vitamin MPteroyl-L-glutamic acid Vitamin B12 Cobalamin Cyanocobalamin Vitamin CAscorbic acid

Various other compounds have been classified as vitamins by someauthorities. These compounds may be termed pseudo-vitamins and include,but are not limited to, compounds such as ubiquinone (coenzyme Q10),pangamic acid, dimethylglycine, taestrile, amygdaline, flavanoids,para-aminobenzoic acid, adenine, adenylic acid, and s-methylmethionine.As used herein, the term vitamin includes pseudo-vitamins.

In some embodiments, the vitamin is a fat-soluble vitamin chosen fromvitamin A, D, E, K and combinations thereof.

In other embodiments, the vitamin is a water-soluble vitamin chosen fromvitamin B1, vitamin B2, vitamin B3, vitamin B6, vitamin B12, folic acid,biotin, pantothenic acid, vitamin C and combinations thereof.

Glucosamine

In certain embodiments, the functional ingredient is glucosamine.

Generally, according to particular embodiments of this invention,glucosamine is present in the compositions in an amount sufficient topromote health and wellness.

Glucosamine, also called chitosamine, is an amino sugar that is believedto be an important precursor in the biochemical synthesis ofglycosylated proteins and lipids. D-glucosamine occurs naturally in thecartilage in the form of glucosamine-6-phosphate, which is synthesizedfrom fructose-6-phosphate and glutamine. However, glucosamine also isavailable in other forms, non-limiting examples of which includeglucosamine hydrochloride, glucosamine sulfate, N-acetyl-glucosamine, orany other salt forms or combinations thereof. Glucosamine may beobtained by acid hydrolysis of the shells of lobsters, crabs, shrimps,or prawns using methods well known to those of ordinary skill in theart. In a particular embodiment, glucosamine may be derived from fungalbiomass containing chitin, as described in U.S. Patent Publication No.2006/0172392.

The compositions can further comprise chondroitin sulfate.

Mineral

In certain embodiments, the functional ingredient is at least onemineral.

As used herein, the at least one mineral may be single mineral or aplurality of minerals as a functional ingredient for the compositionsprovided herein. Generally, according to particular embodiments of thisinvention, the at least one mineral is present in the composition in anamount sufficient to promote health and wellness.

Minerals, in accordance with the teachings of this invention, compriseinorganic chemical elements required by living organisms. Minerals arecomprised of a broad range of compositions (e.g., elements, simplesalts, and complex silicates) and also vary broadly in crystallinestructure. They may naturally occur in foods and beverages, may be addedas a supplement, or may be consumed or administered separately fromfoods or beverages.

Minerals may be categorized as either bulk minerals, which are requiredin relatively large amounts, or trace minerals, which are required inrelatively small amounts. Bulk minerals generally are required inamounts greater than or equal to about 100 mg per day and trace mineralsare those that are required in amounts less than about 100 mg per day.

In particular embodiments of this invention, the mineral is chosen frombulk minerals, trace minerals or combinations thereof. Non-limitingexamples of bulk minerals include calcium, chlorine, magnesium,phosphorous, potassium, sodium, and sulfur. Non-limiting examples oftrace minerals include chromium, cobalt, copper, fluorine, iron,manganese, molybdenum, selenium, zinc, and iodine. Although iodinegenerally is classified as a trace mineral, it is required in largerquantities than other trace minerals and often is categorized as a bulkmineral.

In other particular embodiments of this invention, the mineral is atrace mineral, believed to be necessary for human nutrition,non-limiting examples of which include bismuth, boron, lithium, nickel,rubidium, silicon, strontium, tellurium, tin, titanium, tungsten, andvanadium.

The minerals embodied herein may be in any form known to those ofordinary skill in the art. For example, in a particular embodiment theminerals may be in their ionic form, having either a positive ornegative charge. In another particular embodiment the minerals may be intheir molecular form. For example, sulfur and phosphorous often arefound naturally as sulfates, sulfides, and phosphates.

Preservative

In certain embodiments, the functional ingredient is at least onepreservative.

As used herein, the at least one preservative may be single preservativeor a plurality of preservatives as a functional ingredient for thecompositions provided herein. Generally, according to particularembodiments of this invention, the at least one preservative is presentin the composition in an amount sufficient to promote health andwellness.

In particular embodiments of this invention, the preservative is chosenfrom antimicrobials, antioxidants, antienzymatics or combinationsthereof. Non-limiting examples of antimicrobials include sulfites,propionates, benzoates, sorbates, nitrates, nitrites, bacteriocins,salts, sugars, acetic acid, dimethyl dicarbonate (DMDC), ethanol, andozone.

According to a particular embodiment, the preservative is a sulfite.Sulfites include, but are not limited to, sulfur dioxide, sodiumbisulfite, and potassium hydrogen sulfite.

According to another particular embodiment, the preservative is apropionate. Propionates include, but are not limited to, propionic acid,calcium propionate, and sodium propionate.

According to yet another particular embodiment, the preservative is abenzoate. Benzoates include, but are not limited to, sodium benzoate andbenzoic acid.

In another particular embodiment, the preservative is a sorbate.Sorbates include, but are not limited to, potassium sorbate, sodiumsorbate, calcium sorbate, and sorbic acid.

In still another particular embodiment, the preservative is a nitrateand/or a nitrite. Nitrates and nitrites include, but are not limited to,sodium nitrate and sodium nitrite.

In yet another particular embodiment, the at least one preservative is abacteriocin, such as, for example, nisin.

In another particular embodiment, the preservative is ethanol.

In still another particular embodiment, the preservative is ozone.

Non-limiting examples of antienzymatics suitable for use aspreservatives in particular embodiments of the invention includeascorbic acid, citric acid, and metal chelating agents such asethylenediaminetetraacetic acid (EDTA).

Hydration Agent

In certain embodiments, the functional ingredient is at least onehydration agent.

As used herein, the at least one hydration agent may be single hydrationagent or a plurality of hydration agents as a functional ingredient forthe compositions provided herein. Generally, according to particularembodiments of this invention, the at least one hydration agent ispresent in the composition in an amount sufficient to promote health andwellness.

Hydration products help the body to replace fluids that are lost throughexcretion. For example, fluid is lost as sweat in order to regulate bodytemperature, as urine in order to excrete waste substances, and as watervapor in order to exchange gases in the lungs. Fluid loss can also occurdue to a wide range of external causes, non-limiting examples of whichinclude physical activity, exposure to dry air, diarrhea, vomiting,hyperthermia, shock, blood loss, and hypotension. Diseases causing fluidloss include diabetes, cholera, gastroenteritis, shigellosis, and yellowfever. Forms of malnutrition that cause fluid loss include the excessiveconsumption of alcohol, electrolyte imbalance, fasting, and rapid weightloss.

In a particular embodiment, the hydration product is a composition thathelps the body replace fluids that are lost during exercise.Accordingly, in a particular embodiment, the hydration product is anelectrolyte, non-limiting examples of which include sodium, potassium,calcium, magnesium, chloride, phosphate, bicarbonate, and combinationsthereof. Suitable electrolytes for use in particular embodiments of thisinvention are also described in U.S. Pat. No. 5,681,569, the disclosureof which is expressly incorporated herein by reference. In particularembodiments, the electrolytes are obtained from their correspondingwater-soluble salts. Non-limiting examples of salts for use inparticular embodiments include chlorides, carbonates, sulfates,acetates, bicarbonates, citrates, phosphates, hydrogen phosphates,tartrates, sorbates, citrates, benzoates, or combinations thereof. Inother embodiments, the electrolytes are provided by juice, fruitextracts, vegetable extracts, tea, or teas extracts.

In particular embodiments of this invention, the hydration product is acarbohydrate to supplement energy stores burned by muscles. Suitablecarbohydrates for use in particular embodiments of this invention aredescribed in U.S. Pat. Nos. 4,312,856, 4,853,237, 5,681,569, and6,989,171, the disclosures of which are expressly incorporated herein byreference. Non-limiting examples of suitable carbohydrates includemonosaccharides, disaccharides, oligosaccharides, complexpolysaccharides or combinations thereof. Non-limiting examples ofsuitable types of monosaccharides for use in particular embodimentsinclude trioses, tetroses, pentoses, hexoses, heptoses, octoses, andnonoses. Non-limiting examples of specific types of suitablemonosaccharides include glyceraldehyde, dihydroxyacetone, erythrose,threose, erythrulose, arabinose, lyxose, ribose, xylose, ribulose,xylulose, allose, altrose, galactose, glucose, gulose, idose, mannose,talose, fructose, psicose, sorbose, tagatose, mannoheptulose,sedoheltulose, octolose, and sialose. Non-limiting examples of suitabledisaccharides include sucrose, lactose, and maltose. Non-limitingexamples of suitable oligosaccharides include saccharose, maltotriose,and maltodextrin. In other particular embodiments, the carbohydrates areprovided by a corn syrup, a beet sugar, a cane sugar, a juice, or a tea.

In another particular embodiment, the hydration is a flavanol thatprovides cellular rehydration. Flavanols are a class of naturalsubstances present in plants, and generally comprise a2-phenylbenzopyrone molecular skeleton attached to one or more chemicalmoieties. Non-limiting examples of suitable flavanols for use inparticular embodiments of this invention include catechin, epicatechin,gallocatechin, epigallocatechin, epicatechin gallate, epigallocatechin3-gallate, theaflavin, theaflavin 3-gallate, theaflavin 3′-gallate,theaflavin 3,3′ gallate, thearubigin or combinations thereof. Severalcommon sources of flavanols include tea plants, fruits, vegetables, andflowers. In preferred embodiments, the flavanol is extracted from greentea.

In a particular embodiment, the hydration product is a glycerol solutionto enhance exercise endurance. The ingestion of a glycerol containingsolution has been shown to provide beneficial physiological effects,such as expanded blood volume, lower heart rate, and lower rectaltemperature.

Probiotics/Prebiotics

In certain embodiments, the functional ingredient is chosen from atleast one probiotic, prebiotic and combination thereof.

As used herein, the at least one probiotic or prebiotic may be singleprobiotic or prebiotic or a plurality of probiotics or prebiotics as afunctional ingredient for the compositions provided herein. Generally,according to particular embodiments of this invention, the at least oneprobiotic, prebiotic or combination thereof is present in thecomposition in an amount sufficient to promote health and wellness.

Probiotics, in accordance with the teachings of this invention, comprisemicroorganisms that benefit health when consumed in an effective amount.Desirably, probiotics beneficially affect the human body'snaturally-occurring gastrointestinal microflora and impart healthbenefits apart from nutrition. Probiotics may include, withoutlimitation, bacteria, yeasts, and fungi.

Prebiotics, in accordance with the teachings of this invention, arecompositions that promote the growth of beneficial bacteria in theintestines. Prebiotic substances can be consumed by a relevantprobiotic, or otherwise assist in keeping the relevant probiotic aliveor stimulate its growth. When consumed in an effective amount,prebiotics also beneficially affect the human body's naturally-occurringgastrointestinal microflora and thereby impart health benefits apartfrom just nutrition. Prebiotic foods enter the colon and serve assubstrate for the endogenous bacteria, thereby indirectly providing thehost with energy, metabolic substrates, and essential micronutrients.The body's digestion and absorption of prebiotic foods is dependent uponbacterial metabolic activity, which salvages energy for the host fromnutrients that escaped digestion and absorption in the small intestine.

According to particular embodiments, the probiotic is a beneficialmicroorganism that beneficially affects the human body'snaturally-occurring gastrointestinal microflora and imparts healthbenefits apart from nutrition. Examples of probiotics include, but arenot limited to, bacteria of the genus Lactobacilli, Bifidobacteria,Streptococci, or combinations thereof, that confer beneficial effects tohumans.

In particular embodiments of the invention, the at least one probioticis chosen from the genus Lactobacilli. Lactobacilli (i.e., bacteria ofthe genus Lactobacillus, hereinafter “L.”) have been used for severalhundred years as a food preservative and for promoting human health.Non-limiting examples of species of Lactobacilli found in the humanintestinal tract include L. acidophilus, L. casei, L. fermentum, L.saliva roes, L. brevis, L. leichmannii, L. plantarum, L. cellobiosus, L.reuteri, L. rhamnosus, L. GG, L. bulgaricus, and L. thermophilus.

According to other particular embodiments of this invention, theprobiotic is chosen from the genus Bifidobacteria. Bifidobacteria alsoare known to exert a beneficial influence on human health by producingshort chain fatty acids (e.g., acetic, propionic, and butyric acids),lactic, and formic acids as a result of carbohydrate metabolism.Non-limiting species of Bifidobacteria found in the humangastrointestinal tract include B. angulatum, B. animalis, B. asteroides,B. bifidum, B. boum, B. breve, B. catenulatum, B. choerinum, B.coryneforme, B. cuniculi, B. dentium, B. gallicum, B. gallinarum, Bindicum, B. longum, B. magnum, B. merycicum, B. minimum, B.pseudocatenulatum, B. pseudolongum, B. psychraerophilum, B. pullorum, B.ruminantium, B. saeculare, B. scardovii, B. simiae, B. subtile, B.thermacidophilum, B. thermophilum, B. urinalis, and B. sp.

According to other particular embodiments of this invention, theprobiotic is chosen from the genus Streptococcus. Streptococcusthermophilus is a gram-positive facultative anaerobe. It is classifiedas a lactic acid bacteria and commonly is found in milk and milkproducts, and is used in the production of yogurt. Other non-limitingprobiotic species of this bacteria include Streptococcus salivarus andStreptococcus cremoris.

Probiotics that may be used in accordance with this invention arewell-known to those of skill in the art. Non-limiting examples offoodstuffs comprising probiotics include yogurt, sauerkraut, kefir,kimchi, fermented vegetables, and other foodstuffs containing amicrobial element that beneficially affects the host animal by improvingthe intestinal microbalance.

Prebiotics, in accordance with the embodiments of this invention,include, without limitation, mucopolysaccharides, oligosaccharides,polysaccharides, amino acids, vitamins, nutrient precursors, proteinsand combinations thereof.

According to a particular embodiment of this invention, the prebiotic ischosen from dietary fibers, including, without limitation,polysaccharides and oligosaccharides. These compounds have the abilityto increase the number of probiotics, which leads to the benefitsconferred by the probiotics. Non-limiting examples of oligosaccharidesthat are categorized as prebiotics in accordance with particularembodiments of this invention include fructooligosaccharides, inulins,isomalto-oligosaccharides, lactilol, lactosucrose, lactulose,pyrodextrins, soy oligosaccharides, transgalacto-oligosaccharides, andxylo-oligosaccharides.

According to other particular embodiments of the invention, theprebiotic is an amino acid. Although a number of known prebiotics breakdown to provide carbohydrates for probiotics, some probiotics alsorequire amino acids for nourishment.

Prebiotics are found naturally in a variety of foods including, withoutlimitation, bananas, berries, asparagus, garlic, wheat, oats, barley(and other whole grains), flaxseed, tomatoes, Jerusalem artichoke,onions and chicory, greens (e.g., dandelion greens, spinach, collardgreens, chard, kale, mustard greens, turnip greens), and legumes (e.g.,lentils, kidney beans, chickpeas, navy beans, white beans, black beans).

Weight Management Agent

In certain embodiments, the functional ingredient is at least one weightmanagement agent.

As used herein, the at least one weight management agent may be singleweight management agent or a plurality of weight management agents as afunctional ingredient for the compositions provided herein. Generally,according to particular embodiments of this invention, the at least oneweight management agent is present in the composition in an amountsufficient to promote health and wellness.

As used herein, “a weight management agent” includes an appetitesuppressant and/or a thermogenesis agent. As used herein, the phrases“appetite suppressant”, “appetite satiation compositions”, “satietyagents”, and “satiety ingredients” are synonymous. The phrase “appetitesuppressant” describes macronutrients, herbal extracts, exogenoushormones, anorectics, anorexigenics, pharmaceutical drugs, andcombinations thereof, that when delivered in an effective amount,suppress, inhibit, reduce, or otherwise curtail a person's appetite. Thephrase “thermogenesis agent” describes macronutrients, herbal extracts,exogenous hormones, anorectics, anorexigenics, pharmaceutical drugs, andcombinations thereof, that when delivered in an effective amount,activate or otherwise enhance a person's thermogenesis or metabolism.

Suitable weight management agents include macronutrient selected fromthe group consisting of proteins, carbohydrates, dietary fats, andcombinations thereof. Consumption of proteins, carbohydrates, anddietary fats stimulates the release of peptides withappetite-suppressing effects. For example, consumption of proteins anddietary fats stimulates the release of the gut hormone cholecytokinin(CCK), while consumption of carbohydrates and dietary fats stimulatesrelease of Glucagon-like peptide 1 (GLP-1).

Suitable macronutrient weight management agents also includecarbohydrates. Carbohydrates generally comprise sugars, starches,cellulose and gums that the body converts into glucose for energy.Carbohydrates often are classified into two categories, digestiblecarbohydrates (e.g., monosaccharides, disaccharides, and starch) andnon-digestible carbohydrates (e.g., dietary fiber). Studies have shownthat non-digestible carbohydrates and complex polymeric carbohydrateshaving reduced absorption and digestibility in the small intestinestimulate physiologic responses that inhibit food intake. Accordingly,the carbohydrates embodied herein desirably comprise non-digestiblecarbohydrates or carbohydrates with reduced digestibility. Non-limitingexamples of such carbohydrates include polydextrose; inulin;monosaccharide-derived polyols such as erythritol, mannitol, xylitol,and sorbitol; disaccharide-derived alcohols such as isomalt, lactitol,and maltitol; and hydrogenated starch hydrolysates. Carbohydrates aredescribed in more detail herein below.

In another particular embodiment weight management agent is a dietaryfat. Dietary fats are lipids comprising combinations of saturated andunsaturated fatty acids. Polyunsaturated fatty acids have been shown tohave a greater satiating power than mono-unsaturated fatty acids.Accordingly, the dietary fats embodied herein desirably comprisepoly-unsaturated fatty acids, non-limiting examples of which includetriacylglycerols.

In a particular embodiment, the weight management agents is an herbalextract. Extracts from numerous types of plants have been identified aspossessing appetite suppressant properties. Non-limiting examples ofplants whose extracts have appetite suppressant properties includeplants of the genus Hoodia, Trichocaulon, Caralluma, Stapelia, Orbea,Asclepias, and Camelia. Other embodiments include extracts derived fromGymnema Sylvestre, Kola Nut, Citrus Auran tium, Yerba Mate, GriffoniaSimplicifolia, Guarana, myrrh, guggul Lipid, and black current seed oil.

The herbal extracts may be prepared from any type of plant material orplant biomass. Non-limiting examples of plant material and biomassinclude the stems, roots, leaves, dried powder obtained from the plantmaterial, and sap or dried sap. The herbal extracts generally areprepared by extracting sap from the plant and then spray-drying the sap.Alternatively, solvent extraction procedures may be employed. Followingthe initial extraction, it may be desirable to further fractionate theinitial extract (e.g., by column chromatography) in order to obtain anherbal extract with enhanced activity. Such techniques are well known tothose of ordinary skill in the art.

In a particular embodiment, the herbal extract is derived from a plantof the genus Hoodia, species of which include H. alstonii, H. currorii,H. dregei, H. flava, H. gordonii, H. jutatae, H. mossamedensis, H.officinalis, H. parviflorai, H. pedicellata, H. pilifera, H. ruschii,and H. triebneri. Hoodia plants are stem succulents native to southernAfrica. A sterol glycoside of Hoodia, known as P57, is believed to beresponsible for the appetite-suppressant effect of the Hoodia species.

In another particular embodiment, the herbal extract is derived from aplant of the genus Caralluma, species of which include C. indica, C.fimbriata, C. attenuate, C. tuberculata, C. edulis, C. adscendens, C.stalagmifera, C. umbellate, C. penicillata, C. russeliana, C.retrospicens, C. arabica, and C. lasiantha. Caralluma plants belong tothe same Subfamily as Hoodia, Asclepiadaceae. Caralluma are small, erectand fleshy plants native to India having medicinal properties, such asappetite suppression, that generally are attributed to glycosidesbelonging to the pregnane group of glycosides, non-limiting examples ofwhich include caratuberside A, caratuberside B, bouceroside I,bouceroside II, bouceroside III, bouceroside IV, bouceroside V,bouceroside VI, bouceroside VII, bouceroside VIII, bouceroside IX, andbouceroside X.

In another particular embodiment, the at least one herbal extract isderived from a plant of the genus Trichocaulon. Trichocaulon plants aresucculents that generally are native to southern Africa, similar toHoodia, and include the species T. piliferum and T. officinale.

In another particular embodiment, the herbal extract is derived from aplant of the genus Stapelia or Orbea, species of which include S.gigantean and O. variegate, respectively. Both Stapelia and Orbea plantsbelong to the same Subfamily as Hoodia, Asclepiadaceae. Not wishing tobe bound by any theory, it is believed that the compounds exhibitingappetite suppressant activity are saponins, such as pregnane glycosides,which include stavarosides A, B, C, D, E, F, G, H, I, J, and K.

In another particular embodiment, the herbal extract is derived from aplant of the genus Asclepias. Asclepias plants also belong to theAsclepiadaceae family of plants. Non-limiting examples of Asclepiasplants include A. incarnate, A. curassayica, A. syriaca, and A.tuberose. Not wishing to be bound by any theory, it is believed that theextracts comprise steroidal compounds, such as pregnane glycosides andpregnane aglycone, having appetite suppressant effects.

In a particular embodiment, the weight management agent is an exogenoushormone having a weight management effect. Non-limiting examples of suchhormones include CCK, peptide YY, ghrelin, bombesin andgastrin-releasing peptide (GRP), enterostatin, apolipoprotein A-IV,GLP-1, amylin, somastatin, and leptin.

In another embodiment, the weight management agent is a pharmaceuticaldrug. Non-limiting examples include phentenime, diethylpropion,phendimetrazine, sibutramine, rimonabant, oxyntomodulin, floxetinehydrochloride, ephedrine, phenethylamine, or other stimulants.

Osteoporosis Management Agent

In certain embodiments, the functional ingredient is at least oneosteoporosis management agent.

As used herein, the at least one osteoporosis management agent may besingle osteoporosis management agent or a plurality of osteoporosismanagement agent as a functional ingredient for the compositionsprovided herein. Generally, according to particular embodiments of thisinvention, the at least one osteoporosis management agent is present inthe composition in an amount sufficient to promote health and wellness.

Osteoporosis is a skeletal disorder of compromised bone strength,resulting in an increased risk of bone fracture. Generally, osteoporosisis characterized by reduction of the bone mineral density (BMD),disruption of bone micro-architecture, and changes to the amount andvariety of non-collagenous proteins in the bone.

In certain embodiments, the osteoporosis management agent is at leastone calcium source. According to a particular embodiment, the calciumsource is any compound containing calcium, including salt complexes,solubilized species, and other forms of calcium. Non-limiting examplesof calcium sources include amino acid chelated calcium, calciumcarbonate, calcium oxide, calcium hydroxide, calcium sulfate, calciumchloride, calcium phosphate, calcium hydrogen phosphate, calciumdihydrogen phosphate, calcium citrate, calcium malate, calcium citratemalate, calcium gluconate, calcium tartrate, calcium lactate,solubilized species thereof, and combinations thereof.

According to a particular embodiment, the osteoporosis management agentis a magnesium source. The magnesium source is any compound containingmagnesium, including salt complexes, solubilized species, and otherforms of magnesium. Non-limiting examples of magnesium sources includemagnesium chloride, magnesium citrate, magnesium gluceptate, magnesiumgluconate, magnesium lactate, magnesium hydroxide, magnesium picolate,magnesium sulfate, solubilized species thereof, and mixtures thereof. Inanother particular embodiment, the magnesium source comprises an aminoacid chelated or creatine chelated magnesium.

In other embodiments, the osteoporosis agent is chosen from vitamins D,C, K, their precursors and/or beta-carotene and combinations thereof.

Numerous plants and plant extracts also have been identified as beingeffective in the prevention and treatment of osteoporosis. Not wishingto be bound by any theory, it is believed that the plants and plantextracts stimulates bone morphogenic proteins and/or inhibits boneresorption, thereby stimulating bone regeneration and strength.Non-limiting examples of suitable plants and plant extracts asosteoporosis management agents include species of the genus Taraxacumand Amelanchier, as disclosed in U.S. Patent Publication No.2005/0106215, and species of the genus Lindera, Artemisia, Acorus,Carthamus, Carum, Cnidium, Curcuma, Cyperus, Juniperus, Prunus, Iris,Cichorium, Dodonaea, Epimedium, Erigonoum, Soya, Mentha, Ocimum, thymus,Tanacetum, Plantago, Spearmint, Bixa, Vitis, Rosemarinus, Rhus, andAnethum, as disclosed in U.S. Patent Publication No. 2005/0079232.

Phytoestrogen

In certain embodiments, the functional ingredient is at least onephytoestrogen.

As used herein, the at least one phytoestrogen may be singlephytoestrogen or a plurality of phytoestrogens as a functionalingredient for the compositions provided herein. Generally, according toparticular embodiments of this invention, the at least one phytoestrogenis present in the composition in an amount sufficient to promote healthand wellness.

Phytoestrogens are compounds found in plants which can typically bedelivered into human bodies by ingestion of the plants or the plantparts having the phytoestrogens. As used herein, “phytoestrogen” refersto any substance which, when introduced into a body causes anestrogen-like effect of any degree. For example, a phytoestrogen maybind to estrogen receptors within the body and have a smallestrogen-like effect.

Examples of suitable phytoestrogens for embodiments of this inventioninclude, but are not limited to, isoflavones, stilbenes, lignans,resorcyclic acid lactones, coumestans, coumestroI, equol, andcombinations thereof. Sources of suitable phytoestrogens include, butare not limited to, whole grains, cereals, fibers, fruits, vegetables,black cohosh, agave root, black currant, black haw, chasteberries, crampbark, dong quai root, devil's club root, false unicorn root, ginsengroot, groundsel herb, licorice, liferoot herb, motherwort herb, peonyroot, raspberry leaves, rose family plants, sage leaves, sarsaparillaroot, saw palmetto berried, wild yam root, yarrow blossoms, legumes,soybeans, soy products (e.g., miso, soy flour, soymilk, soy nuts, soyprotein isolate, tempen, or tofu) chick peas, nuts, lentils, seeds,clover, red clover, dandelion leaves, dandelion roots, fenugreek seeds,green tea, hops, red wine, flaxseed, garlic, onions, linseed, borage,butterfly weed, caraway, chaste tree, vitex, dates, dill, fennel seed,gotu kola, milk thistle, pennyroyal, pomegranates, southernwood, soyaflour, tansy, and root of the kudzu vine (pueraria root) and the like,and combinations thereof.

Isoflavones belong to the group of phytonutrients called polyphenols. Ingeneral, polyphenols (also known as “polyphenolics”), are a group ofchemical substances found in plants, characterized by the presence ofmore than one phenol group per molecule.

Suitable phytoestrogen isoflavones in accordance with embodiments ofthis invention include genistein, daidzein, glycitein, biochanin A,formononetin, their respective naturally occurring glycosides andglycoside conjugates, matairesinol, secoisolariciresinol, enterolactone,enterodiol, textured vegetable protein, and combinations thereof.

Suitable sources of isoflavones for embodiments of this inventioninclude, but are not limited to, soy beans, soy products, legumes,alfalfa sprouts, chickpeas, peanuts, and red clover.

Long-Chain Primary Aliphatic Saturated Alcohol

In certain embodiments, the functional ingredient is at least one longchain primary aliphatic saturated alcohol.

As used herein, the at least one long chain primary aliphatic saturatedalcohol may be single long chain primary aliphatic saturated alcohol ora plurality of long chain primary aliphatic saturated alcohols as afunctional ingredient for the compositions provided herein. Generally,according to particular embodiments of this invention, the at least onelong chain primary aliphatic saturated alcohol is present in thecomposition in an amount sufficient to promote health and wellness.

Long-chain primary aliphatic saturated alcohols are a diverse group oforganic compounds. The term alcohol refers to the fact these compoundsfeature a hydroxyl group (—OH) bound to a carbon atom. The term primaryrefers to the fact that in these compounds the carbon atom which isbound to the hydroxyl group is bound to only one other carbon atom. Theterm saturated refers to the fact that these compounds feature no carbonto carbon pi bonds. The term aliphatic refers to the fact that thecarbon atoms in these compounds are joined together in straight orbranched chains rather than in rings. The term long-chain refers to thefact that the number of carbon atoms in these compounds is at least 8carbons).

Non-limiting examples of particular long-chain primary aliphaticsaturated alcohols for use in particular embodiments of the inventioninclude the 8 carbon atom 1-octanol, the 9 carbon 1-nonanol, the 10carbon atom 1-decanol, the 12 carbon atom 1-dodecanol, the 14 carbonatom 1-tetradecanol, the 16 carbon atom 1-hexadecanol, the 18 carbonatom 1-octadecanol, the 20 carbon atom 1-eicosanol, the 22 carbon1-docosanol, the 24 carbon 1-tetracosanol, the 26 carbon 1-hexacosanol,the 27 carbon 1-heptacosanol, the 28 carbon 1-octanosol, the 29 carbon1-nonacosanol, the 30 carbon 1-triacontanol, the 32 carbon1-dotriacontanol, and the 34 carbon 1-tetracontanol.

In a particularly desirable embodiment of the invention, the long-chainprimary aliphatic saturated alcohols are policosanol. Policosanol is theterm for a mixture of long-chain primary aliphatic saturated alcoholscomposed primarily of 28 carbon 1-octanosol and 30 carbon1-triacontanol, as well as other alcohols in lower concentrations suchas 22 carbon 1-docosanol, 24 carbon 1-tetracosanol, 26 carbon1-hexacosanol, 27 carbon 1-heptacosanol, 29 carbon 1-nonacosanol, 32carbon 1-dotriacontanol, and 34 carbon 1-tetracontanol.

Long-chain primary aliphatic saturated alcohols are derived from naturalfats and oils. They may be obtained from these sources by usingextraction techniques well known to those of ordinary skill in the art.Policosanols can be isolated from a variety of plants and materialsincluding sugar cane (Saccharum officinarium), yams (e.g. Dioscoreaopposite), bran from rice (e.g. Oryza sativa), and beeswax. Policosanolsmay be obtained from these sources by using extraction techniques wellknown to those of ordinary skill in the art. A description of suchextraction techniques can be found in U.S. Pat. Appl. No. 2005/0220868,the disclosure of which is expressly incorporated by reference.

Phytosterols

In certain embodiments, the functional ingredient is at least onephytosterol, phytostanol or combination thereof.

Generally, according to particular embodiments of this invention, the atleast one phytosterol, phytostanol or combination thereof is present inthe composition in an amount sufficient to promote health and wellness.

As used herein, the phrases “stanol”, “plant stanol” and “phytostanol”are synonymous.

Plant sterols and stanols are present naturally in small quantities inmany fruits, vegetables, nuts, seeds, cereals, legumes, vegetable oils,bark of the trees and other plant sources. Although people normallyconsume plant sterols and stanols every day, the amounts consumed areinsufficient to have significant cholesterol-lowering effects or otherhealth benefits. Accordingly, it would be desirable to supplement foodand beverages with plant sterols and stanols.

Sterols are a subgroup of steroids with a hydroxyl group at C-3.Generally, phytosterols have a double bond within the steroid nucleus,like cholesterol; however, phytosterols also may comprise a substitutedsidechain (R) at C-24, such as an ethyl or methyl group, or anadditional double bond. The structures of phytosterols are well known tothose of skill in the art.

At least 44 naturally-occurring phytosterols have been discovered, andgenerally are derived from plants, such as corn, soy, wheat, and woodoils; however, they also may be produced synthetically to formcompositions identical to those in nature or having properties similarto those of naturally-occurring phytosterols. According to particularembodiments of this invention, non-limiting examples of phytosterolswell known to those or ordinary skill in the art include4-desmethylsterols (e.g., β-sitosterol, campesterol, stigmasterol,brassicasterol, 22-dehydrobrassicasterol, and Δ5-avenasterol),4-monomethyl sterols, and 4,4-dimethyl sterols (triterpene alcohols)(e.g., cycloartenol, 24-methylenecycloartanol, and cyclobranol).

As used herein, the phrases “stanol”, “plant stanol” and “phytostanol”are synonymous. Phytostanols are saturated sterol alcohols present inonly trace amounts in nature and also may be synthetically produced,such as by hydrogenation of phytosterols. According to particularembodiments of this invention, non-limiting examples of phytostanolsinclude β-sitostanol, campestanol, cycloartanol, and saturated forms ofother triterpene alcohols.

Both phytosterols and phytostanols, as used herein, include the variousisomers such as the a and β isomers (e.g., α-sitosterol andβ-sitostanol, which comprise one of the most effective phytosterols andphytostanols, respectively, for lowering serum cholesterol in mammals).

The phytosterols and phytostanols of the present invention also may bein their ester form. Suitable methods for deriving the esters ofphytosterols and phytostanols are well known to those of ordinary skillin the art, and are disclosed in U.S. Pat. Nos. 6,589,588, 6,635,774,6,800,317, and U.S. Patent Publication Number 2003/0045473, thedisclosures of which are incorporated herein by reference in theirentirety. Non-limiting examples of suitable phytosterol and phytostanolesters include sitosterol acetate, sitosterol oleate, stigmasterololeate, and their corresponding phytostanol esters. The phytosterols andphytostanols of the present invention also may include theirderivatives.

Generally, the amount of functional ingredient in the composition varieswidely depending on the particular composition and the desiredfunctional ingredient. Those of ordinary skill in the art will readilyascertain the appropriate amount of functional ingredient for eachcomposition.

In one embodiment, a method for preparing a composition comprisescombining HSG-Extract and at least one sweetener and/or additive and/orfunctional ingredient.

Consumables

In one embodiment, the composition of the present invention is aconsumable comprising HSG-Extract, or a consumable comprising acomposition comprising HSG-Extract.

HSG-Extract, or a composition comprising the same, can be incorporatedin any known edible or oral composition (referred to herein as a“consumable”), such as, for example, pharmaceutical compositions, ediblegel mixes and compositions, dental compositions, foodstuffs(confections, condiments, chewing gum, cereal compositions baked goodsdairy products, and tabletop sweetener compositions) beverages andbeverage products.

Consumables, as used herein, mean substances which are contacted withthe mouth of man or animal, including substances which are taken intoand subsequently ejected from the mouth and substances which are drunk,eaten, swallowed or otherwise ingested, and are safe for human or animalconsumption when used in a generally acceptable range.

For example, a beverage is a consumable. The beverage may be sweetenedor unsweetened. HSG-Extract, or a composition comprising a HSG-Extract,may be added to a beverage or beverage matrix to sweeten the beverage orenhance its existing sweetness or flavor.

In one embodiment, the present invention is a consumable comprisingHSG-Extract. The concentration of HSG-Extract in the consumable may beabove, at or below its threshold sweetness concentration.

In a particular embodiment, the present invention is a consumablecomprising HSG-Extract. The concentration of HSG-Extract in the beveragemay be above, at or below its threshold sweetness concentration.

The consumable can optionally include additives, additional sweeteners,functional ingredients and combinations thereof, as described herein.Any of the additive, additional sweetener and functional ingredientsdescribed above can be present in the consumable.

Pharmaceutical Compositions

In one embodiment, the present invention is a pharmaceutical compositionthat comprises a pharmaceutically active substance and HSG-Extract.

In another embodiment, the present invention is a pharmaceuticalcomposition that comprises a pharmaceutically active substance and acomposition comprising HSG-Extract.

HSG-Extract or composition comprising HSG-Extract can be present as anexcipient material in the pharmaceutical composition, which can mask abitter or otherwise undesirable taste of a pharmaceutically activesubstance or another excipient material. The pharmaceutical compositionmay be in the form of a tablet, a capsule, a liquid, an aerosol, apowder, an effervescent tablet or powder, a syrup, an emulsion, asuspension, a solution, or any other form for providing thepharmaceutical composition to a patient. In particular embodiments, thepharmaceutical composition may be in a form for oral administration,buccal administration, sublingual administration, or any other route ofadministration as known in the art.

As referred to herein, “pharmaceutically active substance” means anydrug, drug formulation, medication, prophylactic agent, therapeuticagent, or other substance having biological activity. As referred toherein, “excipient material” refers to any inactive substance used as avehicle for an active ingredient, such as any material to facilitatehandling, stability, dispersibility, wettability, and/or releasekinetics of a pharmaceutically active substance.

Suitable pharmaceutically active substances include, but are not limitedto, medications for the gastrointestinal tract or digestive system, forthe cardiovascular system, for the central nervous system, for pain orconsciousness, for musculo-skeletal disorders, for the eye, for the ear,nose and oropharynx, for the respiratory system, for endocrine problems,for the reproductive system or urinary system, for contraception, forobstetrics and gynecology, for the skin, for infections andinfestations, for immunology, for allergic disorders, for nutrition, forneoplastic disorders, for diagnostics, for euthanasia, or otherbiological functions or disorders. Examples of suitable pharmaceuticallyactive substances for embodiments of the present invention include, butare not limited to, antacids, reflux suppressants, antiflatulents,antidopaminergics, proton pump inhibitors, cytoprotectants,prostaglandin analogues, laxatives, antispasmodics, antidiarrhoeals,bile acid sequestrants, opioids, beta-receptor blockers, calcium channelblockers, diuretics, cardiac glycosides, antiarrhythmics, nitrates,antianginals, vasoconstrictors, vasodilators, peripheral activators, ACEinhibitors, angiotensin receptor blockers, alpha blockers,anticoagulants, heparin, antiplatelet drugs, fibrinolytics,anti-hemophilic factors, haemostatic drugs, hypolipidaemic agents,statins, hynoptics, anaesthetics, antipsychotics, antidepressants,anti-emetics, anticonvulsants, antiepileptics, anxiolytics,barbiturates, movement disorder drugs, stimulants, benzodiazepines,cyclopyrrolones, dopamine antagonists, antihistamines, cholinergics,anticholinergics, emetics, cannabinoids, analgesics, muscle relaxants,antibiotics, aminoglycosides, anti-virals, anti-fungals,anti-inflammatories, anti-gluacoma drugs, sympathomimetics, steroids,ceruminolytics, bronchodilators, NSAIDS, antitussive, mucolytics,decongestants, corticosteroids, androgens, antiandrogens, gonadotropins,growth hormones, insulin, antidiabetics, thyroid hormones, calcitonin,diphosponates, vasopressin analogues, alkalizing agents, quinolones,anticholinesterase, sildenafil, oral contraceptives, Hormone ReplacementTherapies, bone regulators, follicle stimulating hormones, luteinizingshormones, gamolenic acid, progestogen, dopamine agonist, oestrogen,prostaglandin, gonadorelin, clomiphene, tamoxifen, diethylstilbestrol,antileprotics, antituberculous drugs, antimalarials, anthelmintics,antiprotozoal, antiserums, vaccines, interferons, tonics, vitamins,cytotoxic drugs, sex hormones, aromatase inhibitors, somatostatininhibitors, or similar type substances, or combinations thereof. Suchcomponents generally are recognized as safe (GRAS) and/or are U.S. Foodand Drug Administration (FDA)-approved.

The pharmaceutically active substance is present in the pharmaceuticalcomposition in widely ranging amounts depending on the particularpharmaceutically active agent being used and its intended applications.An effective dose of any of the herein described pharmaceutically activesubstances can be readily determined by the use of conventionaltechniques and by observing results obtained under analogouscircumstances. In determining the effective dose, a number of factorsare considered including, but not limited to: the species of thepatient; its size, age, and general health; the specific diseaseinvolved; the degree of involvement or the severity of the disease; theresponse of the individual patient; the particular pharmaceuticallyactive agent administered; the mode of administration; thebioavailability characteristic of the preparation administered; the doseregimen selected; and the use of concomitant medication. Thepharmaceutically active substance is included in the pharmaceuticallyacceptable carrier, diluent, or excipient in an amount sufficient todeliver to a patient a therapeutic amount of the pharmaceutically activesubstance in vivo in the absence of serious toxic effects when used ingenerally acceptable amounts. Thus, suitable amounts can be readilydiscerned by those skilled in the art.

According to particular embodiments of the present invention, theconcentration of pharmaceutically active substance in the pharmaceuticalcomposition will depend on absorption, inactivation, and excretion ratesof the drug as well as other factors known to those of skill in the art.It is to be noted that dosage values will also vary with the severity ofthe condition to be alleviated. It is to be further understood that forany particular subject, specific dosage regimes should be adjusted overtime according to the individual need and the professional judgment ofthe person administering or supervising the administration of thepharmaceutical compositions, and that the dosage ranges set forth hereinare exemplary only and are not intended to limit the scope or practiceof the claimed composition. The pharmaceutically active substance may beadministered at once, or may be divided into a number of smaller dosesto be administered at varying intervals of time.

The pharmaceutical composition also may comprise other pharmaceuticallyacceptable excipient materials. Examples of suitable excipient materialsfor embodiments of this invention include, but are not limited to,antiadherents, binders (e.g., microcrystalline cellulose, gumtragacanth, or gelatin), coatings, disintegrants, fillers, diluents,softeners, emulsifiers, flavoring agents, coloring agents, adjuvants,lubricants, functional agents (e.g., nutrients), viscosity modifiers,bulking agents, glidiants (e.g., colloidal silicon dioxide) surfaceactive agents, osmotic agents, diluents, or any other non-activeingredient, or combinations thereof. For example, the pharmaceuticalcompositions of the present invention may include excipient materialsselected from the group consisting of calcium carbonate, coloringagents, whiteners, preservatives, and flavors, triacetin, magnesiumstearate, sterotes, natural or artificial flavors, essential oils, plantextracts, fruit essences, gelatins, or combinations thereof.

The excipient material of the pharmaceutical composition may optionallyinclude other artificial or natural sweeteners, bulk sweeteners, orcombinations thereof. Bulk sweeteners include both caloric andnon-caloric compounds. In a particular embodiment, the additivefunctions as the bulk sweetener. Non-limiting examples of bulksweeteners include sucrose, dextrose, maltose, dextrin, dried invertsugar, fructose, high fructose corn syrup, levulose, galactose, cornsyrup solids, tagatose, polyols (e.g., sorbitol, mannitol, xylitol,lactitol, erythritol, and maltitol), hydrogenated starch hydrolysates,isomalt, trehalose, and mixtures thereof. In particular embodiments, thebulk sweetener is present in the pharmaceutical composition in widelyranging amounts depending on the degree of sweetness desired. Suitableamounts of both sweeteners would be readily discernible to those skilledin the art.

Edible Gel Mixes and Edible Gel Compositions

In one embodiment, the present invention is an edible gel or edible gelmix that comprises HSG-Extract. In another embodiment, the presentinvention is an edible gel or edible gel mix that comprises acomposition comprising HSG-Extract.

Edible gels are gels that can be eaten. A gel is a colloidal system inwhich a network of particles spans the volume of a liquid medium.Although gels mainly are composed of liquids, and thus exhibit densitiessimilar to liquids, gels have the structural coherence of solids due tothe network of particles that spans the liquid medium. For this reason,gels generally appear to be solid, jelly-like materials. Gels can beused in a number of applications. For example, gels can be used infoods, paints, and adhesives.

Non-limiting examples of edible gel compositions for use in particularembodiments include gel desserts, puddings, jellies, pastes, trifles,aspics, marshmallows, gummy candies, or the like. Edible gel mixesgenerally are powdered or granular solids to which a fluid may be addedto form an edible gel composition. Non-limiting examples of fluids foruse in particular embodiments include water, dairy fluids, dairyanalogue fluids, juices, alcohol, alcoholic beverages, and combinationsthereof. Non-limiting examples of dairy fluids which may be used inparticular embodiments include milk, cultured milk, cream, fluid whey,and mixtures thereof. Non-limiting examples of dairy analogue fluidswhich may be used in particular embodiments include, for example, soymilk and non-dairy coffee whitener. Because edible gel products found inthe marketplace typically are sweetened with sucrose, it is desirable tosweeten edible gels with an alternative sweetener in order provide alow-calorie or non-calorie alternative.

As used herein, the term “gelling ingredient” denotes any material thatcan form a colloidal system within a liquid medium. Non-limitingexamples of gelling ingredients for use in particular embodimentsinclude gelatin, alginate, carageenan, gum, pectin, konjac, agar, foodacid, rennet, starch, starch derivatives, and combinations thereof. Itis well known to those having ordinary skill in the art that the amountof gelling ingredient used in an edible gel mix or an edible gelcomposition varies considerably depending on a number of factors, suchas the particular gelling ingredient used, the particular fluid baseused, and the desired properties of the gel.

Edible gel mixes and edible gels may be prepared using ingredientsincluding food acids, a salt of a food acid, a buffering system, abulking agent, a sequestrant, a cross-linking agent, one or moreflavors, one or more colors, and combinations thereof. Non-limitingexamples of food acids for use in particular embodiments include citricacid, adipic acid, fumaric acid, lactic acid, malic acid, andcombinations thereof. Non-limiting examples of salts of food acids foruse in particular embodiments include sodium salts of food acids,potassium salts of food acids, and combinations thereof. Non-limitingexamples of bulking agents for use in particular embodiments includeraftilose, isomalt, sorbitol, polydextrose, maltodextrin, andcombinations thereof. Non-limiting examples of sequestrants for use inparticular embodiments include calcium disodium ethylene tetra-acetate,glucono delta-lactone, sodium gluconate, potassium gluconate,ethylenediaminetetraacetic acid (EDTA), and combinations thereof.Non-limiting examples of cross-linking agents for use in particularembodiments include calcium ions, magnesium ions, sodium ions, andcombinations thereof.

Dental Compositions

In one embodiment, the present invention is a dental composition thatcomprises HSG-Extract. In another embodiment, the present invention is adental composition that comprises a composition comprising HSG-Extract.Dental compositions generally comprise an active dental substance and abase material. HSG-Extract or a composition comprising HSG-Extract canbe used as the base material to sweeten the dental composition. Thedental composition may be in the form of any oral composition used inthe oral cavity such as mouth freshening agents, gargling agents, mouthrinsing agents, toothpaste, tooth polish, dentifrices, mouth sprays,teeth-whitening agent, dental floss, and the like, for example.

As referred to herein, “active dental substance” means any compositionwhich can be used to improve the aesthetic appearance and/or health ofteeth or gums or prevent dental caries. As referred to herein, “basematerial” refers to any inactive substance used as a vehicle for anactive dental substance, such as any material to facilitate handling,stability, dispersibility, wettability, foaming, and/or release kineticsof an active dental substance.

Suitable active dental substances for embodiments of this inventioninclude, but are not limited to, substances which remove dental plaque,remove food from teeth, aid in the elimination and/or masking ofhalitosis, prevent tooth decay, and prevent gum disease (i.e., Gingiva).Examples of suitable active dental substances for embodiments of thepresent invention include, but are not limited to, anticaries drugs,fluoride, sodium fluoride, sodium monofluorophosphate, stannos fluoride,hydrogen peroxide, carbamide peroxide (i.e., urea peroxide),antibacterial agents, plaque removing agents, stain removers,anticalculus agents, abrasives, baking soda, percarbonates, perboratesof alkali and alkaline earth metals, or similar type substances, orcombinations thereof. Such components generally are recognized as safe(GRAS) and/or are U.S. Food and Drug Administration (FDA)-approved.

According to particular embodiments of the invention, the active dentalsubstance is present in the dental composition in an amount ranging fromabout 50 ppm to about 3000 ppm of the dental composition. Generally, theactive dental substance is present in the dental composition in anamount effective to at least improve the aesthetic appearance and/orhealth of teeth or gums marginally or prevent dental caries. Forexample, a dental composition comprising a toothpaste may include anactive dental substance comprising fluoride in an amount of about 850 to1,150 ppm.

The dental composition also may comprise base materials in addition toHSG-Extract or composition comprising HSG-Extract. Examples of suitablebase materials for embodiments of this invention include, but are notlimited to, water, sodium lauryl sulfate or other sulfates, humectants,enzymes, vitamins, herbs, calcium, flavorings (e.g., mint, bubblegum,cinnamon, lemon, or orange), surface-active agents, binders,preservatives, gelling agents, pH modifiers, peroxide activators,stabilizers, coloring agents, or similar type materials, andcombinations thereof.

The base material of the dental composition may optionally include otherartificial or natural sweeteners, bulk sweeteners, or combinationsthereof. Bulk sweeteners include both caloric and non-caloric compounds.Non-limiting examples of bulk sweeteners include sucrose, dextrose,maltose, dextrin, dried invert sugar, fructose, high fructose cornsyrup, levulose, galactose, corn syrup solids, tagatose, polyols (e.g.,sorbitol, mannitol, xylitol, lactitol, erythritol, and maltitol),hydrogenated starch hydrolysates, isomalt, trehalose, and mixturesthereof. Generally, the amount of bulk sweetener present in the dentalcomposition ranges widely depending on the particular embodiment of thedental composition and the desired degree of sweetness. Those ofordinary skill in the art will readily ascertain the appropriate amountof bulk sweetener. In particular embodiments, the bulk sweetener ispresent in the dental composition in an amount in the range of about 0.1to about 5 weight percent of the dental composition.

According to particular embodiments of the invention, the base materialis present in the dental composition in an amount ranging from about 20to about 99 percent by weight of the dental composition. Generally, thebase material is present in an amount effective to provide a vehicle foran active dental substance.

In a particular embodiment, a dental composition comprises HSG-Extractand an active dental substance. In another particular embodiment, adental composition comprises a composition comprising HSG-Extract and anactive dental substance. Generally, the amount of the sweetener varieswidely depending on the nature of the particular dental composition andthe desired degree of sweetness.

Foodstuffs include, but are not limited to, confections, condiments,chewing gum, cereal, baked goods, and dairy products.

Confections

In one embodiment, the present invention is a confection that comprisesHSG-Extract. In another embodiment, the present invention is aconfection that comprises a composition comprising HSG-Extract.

As referred to herein, “confection” can mean a sweet, a lollie, aconfectionery, or similar term. The confection generally contains a basecomposition component and a sweetener component. HSG-Extract or acomposition comprising HSG-Extract can serve as the sweetener component.The confection may be in the form of any food that is typicallyperceived to be rich in sugar or is typically sweet. According toparticular embodiments of the present invention, the confections may bebakery products such as pastries; desserts such as yogurt, jellies,drinkable jellies, puddings, Bavarian cream, blancmange, cakes,brownies, mousse and the like, sweetened food products eaten at tea timeor following meals; frozen foods; cold confections, e. g. types of icecream such as ice cream, ice milk, lacto-ice and the like (food productsin which sweeteners and various other types of raw materials are addedto milk products, and the resulting mixture is agitated and frozen), andice confections such as sherbets, dessert ices and the like (foodproducts in which various other types of raw materials are added to asugary liquid, and the resulting mixture is agitated and frozen);general confections, e. g., baked confections or steamed confectionssuch as crackers, biscuits, buns with bean-jam filling, halvah, alfajor,and the like; rice cakes and snacks; table top products; general sugarconfections such as chewing gum (e.g. including compositions whichcomprise a substantially water-insoluble, chewable gum base, such aschicle or substitutes thereof, including jetulong, guttakay rubber orcertain comestible natural synthetic resins or waxes), hard candy, softcandy, mints, nougat candy, jelly beans, fudge, toffee, taffy, Swissmilk tablet, licorice candy, chocolates, gelatin candies, marshmallow,marzipan, divinity, cotton candy, and the like; sauces including fruitflavored sauces, chocolate sauces and the like; edible gels; crèmesincluding butter crèmes, flour pastes, whipped cream and the like; jamsincluding strawberry jam, marmalade and the like; and breads includingsweet breads and the like or other starch products, and combinationsthereof.

As referred to herein, “base composition” means any composition whichcan be a food item and provides a matrix for carrying the sweetenercomponent.

Suitable base compositions for embodiments of this invention may includeflour, yeast, water, salt, butter, eggs, milk, milk powder, liquor,gelatin, nuts, chocolate, citric acid, tartaric acid, fumaric acid,natural flavors, artificial flavors, colorings, polyols, sorbitol,isomalt, maltitol, lactitol, malic acid, magnesium stearate, lecithin,hydrogenated glucose syrup, glycerine, natural or synthetic gum, starch,and the like, and combinations thereof. Such components generally arerecognized as safe (GRAS) and/or are U.S. Food and Drug Administration(FDA)-approved. According to particular embodiments of the invention,the base composition is present in the confection in an amount rangingfrom about 0.1 to about 99 weight percent of the confection. Generally,the base composition is present in the confection in an amount toprovide a food product.

The base composition of the confection may optionally include otherartificial or natural sweeteners, bulk sweeteners, or combinationsthereof. Bulk sweeteners include both caloric and non-caloric compounds.Non-limiting examples of bulk sweeteners include sucrose, dextrose,maltose, dextrin, dried invert sugar, fructose, high fructose cornsyrup, levulose, galactose, corn syrup solids, tagatose, polyols (e.g.,sorbitol, mannitol, xylitol, lactitol, erythritol, and maltitol),hydrogenated starch hydrolysates, isomalt, trehalose, and mixturesthereof. Generally, the amount of bulk sweetener present in theconfection ranges widely depending on the particular embodiment of theconfection and the desired degree of sweetness. Those of ordinary skillin the art will readily ascertain the appropriate amount of bulksweetener.

In a particular embodiment, a confection comprises HSG-Extract or acomposition comprising HSG-Extract and a base composition. Generally,the amount of HSG-Extract in the confection ranges widely depending onthe particular embodiment of the confection and the desired degree ofsweetness. Those of ordinary skill in the art will readily ascertain theappropriate amount. In a particular embodiment, HSG-Extract is presentin the confection in an amount in the range of about 30 ppm to about6000 ppm of the confection. In another embodiment, HSG-Extract ispresent in the confection in an amount in the range of about 1 ppm toabout 10,000 ppm of the confection. In embodiments where the confectioncomprises hard candy, HSG-Extract is present in an amount in the rangeof about 150 ppm to about 2250 ppm of the hard candy.

Condiment Compositions

In one embodiment, the present invention is a condiment that comprisesHSG-Extract. In another embodiment the present invention is a condimentthat comprises a composition comprising HSG-Extract. Condiments, as usedherein, are compositions used to enhance or improve the flavor of a foodor beverage. Non-limiting examples of condiments include ketchup(catsup); mustard; barbecue sauce; butter; chili sauce; chutney;cocktail sauce; curry; dips; fish sauce; horseradish; hot sauce;jellies, jams, marmalades, or preserves; mayonnaise; peanut butter;relish; remoulade; salad dressings (e.g., oil and vinegar, Caesar,French, ranch, bleu cheese, Russian, Thousand Island, Italian, andbalsamic vinaigrette), salsa; sauerkraut; soy sauce; steak sauce;syrups; tartar sauce; and Worcestershire sauce.

Condiment bases generally comprise a mixture of different ingredients,non-limiting examples of which include vehicles (e.g., water andvinegar); spices or seasonings (e.g., salt, pepper, garlic, mustardseed, onion, paprika, turmeric, and combinations thereof); fruits,vegetables, or their products (e.g., tomatoes or tomato-based products(paste, puree), fruit juices, fruit juice peels, and combinationsthereof); oils or oil emulsions, particularly vegetable oils; thickeners(e.g., xanthan gum, food starch, other hydrocolloids, and combinationsthereof); and emulsifying agents (e.g., egg yolk solids, protein, gumarabic, carob bean gum, guar gum, gum karaya, gum tragacanth,carageenan, pectin, propylene glycol esters of alginic acid, sodiumcarboxymethyl-cellulose, polysorbates, and combinations thereof).Recipes for condiment bases and methods of making condiment bases arewell known to those of ordinary skill in the art.

Generally, condiments also comprise caloric sweeteners, such as sucrose,high fructose corn syrup, molasses, honey, or brown sugar. In exemplaryembodiments of the condiments provided herein, HSG-Extract or acomposition comprising HSG-Extract is used instead of traditionalcaloric sweeteners. Accordingly, a condiment composition desirablycomprises HSG-Extract or a composition comprising HSG-Extract and acondiment base.

The condiment composition optionally may include other natural and/orsynthetic high-potency sweeteners, bulk sweeteners, pH modifying agents(e.g., lactic acid, citric acid, phosphoric acid, hydrochloric acid,acetic acid, and combinations thereof), fillers, functional agents(e.g., pharmaceutical agents, nutrients, or components of a food orplant), flavorings, colorings, or combinations thereof.

Chewing Gum Compositions

In one embodiment, the present invention is a chewing gum compositionthat comprises HSG-Extract. In another embodiment, the present inventionis a chewing gum composition that comprises a composition comprisingHSG-Extract. Chewing gum compositions generally comprise a water-solubleportion and a water-insoluble chewable gum base portion. The watersoluble portion, which typically includes the composition of the presentinvention, dissipates with a portion of the flavoring agent over aperiod of time during chewing while the insoluble gum base portion isretained in the mouth. The insoluble gum base generally determineswhether a gum is considered chewing gum, bubble gum, or a functionalgum.

The insoluble gum base, which is generally present in the chewing gumcomposition in an amount in the range of about 15 to about 35 weightpercent of the chewing gum composition, generally comprises combinationsof elastomers, softeners (plasticizers), emulsifiers, resins, andfillers. Such components generally are considered food grade, recognizedas safe (GRA), and/or are U.S. Food and Drug Administration(FDA)-approved.

Elastomers, the primary component of the gum base, provide the rubbery,cohesive nature to gums and can include one or more natural rubbers(e.g., smoked latex, liquid latex, or guayule); natural gums (e.g.,jelutong, perillo, sorva, massaranduba balata, massaranduba chocolate,nispero, rosindinha, chicle, and gutta hang kang); or syntheticelastomers (e.g., butadiene-styrene copolymers, isobutylene-isoprenecopolymers, polybutadiene, polyisobutylene, and vinyl polymericelastomers). In a particular embodiment, the elastomer is present in thegum base in an amount in the range of about 3 to about 50 weight percentof the gum base.

Resins are used to vary the firmness of the gum base and aid insoftening the elastomer component of the gum base. Non-limiting examplesof suitable resins include a rosin ester, a terpene resin (e.g., aterpene resin from α-pinene, β-pinene and/or d-limonene), polyvinylacetate, polyvinyl alcohol, ethylene vinyl acetate, and vinylacetate-vinyl laurate copolymers. Non-limiting examples of rosin estersinclude a glycerol ester of a partially hydrogenated rosin, a glycerolester of a polymerized rosin, a glycerol ester of a partially dimerizedrosin, a glycerol ester of rosin, a pentaerythritol ester of a partiallyhydrogenated rosin, a methyl ester of rosin, or a methyl ester of apartially hydrogenated rosin. In a particular embodiment, the resin ispresent in the gum base in an amount in the range of about 5 to about 75weight percent of the gum base.

Softeners, which also are known as plasticizers, are used to modify theease of chewing and/or mouthfeel of the chewing gum composition.Generally, softeners comprise oils, fats, waxes, and emulsifiers.Non-limiting examples of oils and fats include tallow, hydrogenatedtallow, large, hydrogenated or partially hydrogenated vegetable oils(e.g., soybean, canola, cottonseed, sunflower, palm, coconut, corn,safflower, or palm kernel oils), cocoa butter, glycerol monostearate,glycerol triacetate, glycerol abietate, leithin, monoglycerides,diglycerides, triglycerides acetylated monoglycerides, and free fattyacids. Non-limiting examples of waxes includepolypropylene/polyethylene/Fisher-Tropsch waxes, paraffin, andmicrocrystalline and natural waxes (e.g., candelilla, beeswax andcarnauba). Microcrystalline waxes, especially those with a high degreeof crystallinity and a high melting point, also may be considered asbodying agents or textural modifiers. In a particular embodiment, thesofteners are present in the gum base in an amount in the range of about0.5 to about 25 weight percent of the gum base.

Emulsifiers are used to form a uniform dispersion of the insoluble andsoluble phases of the chewing gum composition and also have plasticizingproperties. Suitable emulsifiers include glycerol monostearate (GMS),lecithin (Phosphatidyl choline), polyglycerol polyricinoleic acid(PPGR), mono and diglycerides of fatty acids, glycerol distearate,tracetin, acetylated monoglyceride, glycerol triactetate, and magnesiumstearate. In a particular embodiment, the emulsifiers are present in thegum base in an amount in the range of about 2 to about 30 weight percentof the gum base.

The chewing gum composition also may comprise adjuvants or fillers ineither the gum base and/or the soluble portion of the chewing gumcomposition. Suitable adjuvants and fillers include lecithin, inulin,polydextrin, calcium carbonate, magnesium carbonate, magnesium silicate,ground limestome, aluminum hydroxide, aluminum silicate, talc, clay,alumina, titanium dioxide, and calcium phosphate. In particularembodiments, lecithin can be used as an inert filler to decrease thestickiness of the chewing gum composition. In other particularembodiments, lactic acid copolymers, proteins (e.g., gluten and/or zein)and/or guar can be used to create a gum that is more readilybiodegradable. The adjuvants or fillers are generally present in the gumbase in an amount up to about 20 weight percent of the gum base. Otheroptional ingredients include coloring agents, whiteners, preservatives,and flavors.

In particular embodiments of the chewing gum composition, the gum basecomprises about 5 to about 95 weight percent of the chewing gumcomposition, more desirably about 15 to about 50 weight percent of thechewing gum composition, and even more desirably from about 20 to about30 weight percent of the chewing gum composition.

The soluble portion of the chewing gum composition may optionallyinclude other artificial or natural sweeteners, bulk sweeteners,softeners, emulsifiers, flavoring agents, coloring agents, adjuvants,fillers, functional agents (e.g., pharmaceutical agents or nutrients),or combinations thereof. Suitable examples of softeners and emulsifiersare described above.

Bulk sweeteners include both caloric and non-caloric compounds.Non-limiting examples of bulk sweeteners include sucrose, dextrose,maltose, dextrin, dried invert sugar, fructose, high fructose cornsyrup, levulose, galactose, corn syrup solids, tagatose, polyols (e.g.,sorbitol, mannitol, xylitol, lactitol, erythritol, and maltitol),hydrogenated starch hydrolysates, isomalt, trehalose, and mixturesthereof. In particular embodiments, the bulk sweetener is present in thechewing gum composition in an amount in the range of about 1 to about 75weight percent of the chewing gum composition.

Flavoring agents may be used in either the insoluble gum base or solubleportion of the chewing gum composition. Such flavoring agents may benatural or artificial flavors. In a particular embodiment, the flavoringagent comprises an essential oil, such as an oil derived from a plant ora fruit, peppermint oil, spearmint oil, other mint oils, clove oil,cinnamon oil, oil of wintergreen, bay, thyme, cedar leaf, nutmeg,allspice, sage, mace, and almonds. In another particular embodiment, theflavoring agent comprises a plant extract or a fruit essence such asapple, banana, watermelon, pear, peach, grape, strawberry, raspberry,cherry, plum, pineapple, apricot, and mixtures thereof. In still anotherparticular embodiment, the flavoring agent comprises a citrus flavor,such as an extract, essence, or oil of lemon, lime, orange, tangerine,grapefruit, citron, or kumquat.

In a particular embodiment, a chewing gum composition comprisesHSG-Extract or a composition comprising HSG-Extract and a gum base. In aparticular embodiment, HSG-Extract is present in the chewing gumcomposition in an amount in the range of about 1 ppm to about 10,000 ppmof the chewing gum composition.

Cereal Compositions

In one embodiment, the present invention is a cereal composition thatcomprises HSG-Extract. In another embodiment, the present invention is acereal composition that comprises a composition comprising HSG-Extract.Cereal compositions typically are eaten either as staple foods or assnacks. Non-limiting examples of cereal compositions for use inparticular embodiments include ready-to-eat cereals as well as hotcereals. Ready-to-eat cereals are cereals which may be eaten withoutfurther processing (i.e. cooking) by the consumer. Examples ofready-to-eat cereals include breakfast cereals and snack bars. Breakfastcereals typically are processed to produce a shredded, flaky, puffy, orextruded form. Breakfast cereals generally are eaten cold and are oftenmixed with milk and/or fruit. Snack bars include, for example, energybars, rice cakes, granola bars, and nutritional bars. Hot cerealsgenerally are cooked, usually in either milk or water, before beingeaten. Non-limiting examples of hot cereals include grits, porridge,polenta, rice, and rolled oats.

Cereal compositions generally comprise at least one cereal ingredient.As used herein, the term “cereal ingredient” denotes materials such aswhole or part grains, whole or part seeds, and whole or part grass.Non-limiting examples of cereal ingredients for use in particularembodiments include maize, wheat, rice, barley, bran, bran endosperm,bulgur, soghums, millets, oats, rye, triticale, buckwheat, fonio,quinoa, bean, soybean, amaranth, teff, spelt, and kaniwa.

In a particular embodiment, the cereal composition comprises HSG-Extractor a composition comprising HSG-Extract and at least one cerealingredient. HSG-Extract or the composition comprising HSG-Extract may beadded to the cereal composition in a variety of ways, such as, forexample, as a coating, as a frosting, as a glaze, or as a matrix blend(i.e. added as an ingredient to the cereal formulation prior to thepreparation of the final cereal product).

Accordingly, in a particular embodiment, HSG-Extract or a compositioncomprising HSG-Extract is added to the cereal composition as a matrixblend. In one embodiment, HSG-Extract or a composition comprisingHSG-Extract is blended with a hot cereal prior to cooking to provide asweetened hot cereal product. In another embodiment, HSG-Extract or acomposition comprising HSG-Extract is blended with the cereal matrixbefore the cereal is extruded.

In another particular embodiment, HSG-Extract or a compositioncomprising a HSG-Extract is added to the cereal composition as acoating, such as, for example, by combining HSG-Extract or a comprisingHSG-Extract with a food grade oil and applying the mixture onto thecereal. In a different embodiment, HSG-Extract or a compositioncomprising HSG-Extract and the food grade oil may be applied to thecereal separately, by applying either the oil or the sweetener first.Non-limiting examples of food grade oils for use in particularembodiments include vegetable oils such as corn oil, soybean oil,cottonseed oil, peanut oil, coconut oil, canola oil, olive oil, sesameseed oil, palm oil, palm kernel oil, and mixtures thereof. In yetanother embodiment, food grade fats may be used in place of the oils,provided that the fat is melted prior to applying the fat onto thecereal.

In another embodiment, HSG-Extract or a composition comprisingHSG-Extract is added to the cereal composition as a glaze. Non-limitingexamples of glazing agents for use in particular embodiments includecorn syrup, honey syrups and honey syrup solids, maple syrups and maplesyrup solids, sucrose, isomalt, polydextrose, polyols, hydrogenatedstarch hydrolysate, aqueous solutions thereof, and mixtures thereof. Inanother such embodiment, HSG-Extract or a composition comprisingHSG-Extract is added as a glaze by combining with a glazing agent and afood grade oil or fat and applying the mixture to the cereal. In yetanother embodiment, a gum system, such as, for example, gum acacia,carboxymethyl cellulose, or algin, may be added to the glaze to providestructural support. In addition, the glaze also may include a coloringagent, and also may include a flavor.

In another embodiment, HSG-Extract or a composition comprisingHSG-Extract is added to the cereal composition as a frosting. In onesuch embodiment, HSG-Extract or a composition comprising HSG-Extract iscombined with water and a frosting agent and then applied to the cereal.Non-limiting examples of frosting agents for use in particularembodiments include maltodextrin, sucrose, starch, polyols, and mixturesthereof. The frosting also may include a food grade oil, a food gradefat, a coloring agent, and/or a flavor.

Generally, the amount of HSG-Extract in a cereal composition varieswidely depending on the particular type of cereal composition and itsdesired sweetness. Those of ordinary skill in the art can readilydiscern the appropriate amount of sweetener to put in the cerealcomposition. In a particular embodiment, HSG-Extract is present in thecereal composition in an amount in the range of about 0.02 to about 1.5weight percent of the cereal composition and the at least one additiveis present in the cereal composition in an amount in the range of about1 to about 5 weight percent of the cereal composition.

Baked Goods

In one embodiment, the present invention is a baked good that comprisesHSG-Extract. In another embodiment, the present invention is a bakedgood that comprises a composition comprising HSG-Extract. Baked goods,as used herein, include ready to eat and all ready to bake products,flours, and mixes requiring preparation before serving. Non-limitingexamples of baked goods include cakes, crackers, cookies, brownies,muffins, rolls, bagels, donuts, strudels, pastries, croissants,biscuits, bread, bread products, and buns.

Preferred baked goods in accordance with embodiments of this inventioncan be classified into three groups: bread-type doughs (e.g., whitebreads, variety breads, soft buns, hard rolls, bagels, pizza dough, andflour tortillas), sweet doughs (e.g., danishes, croissants, crackers,puff pastry, pie crust, biscuits, and cookies), and batters (e.g., cakessuch as sponge, pound, devil's food, cheesecake, and layer cake, donutsor other yeast raised cakes, brownies, and muffins). Doughs generallyare characterized as being flour-based, whereas batters are morewater-based.

Baked goods in accordance with particular embodiments of this inventiongenerally comprise a combination of sweetener, water, and fat. Bakedgoods made in accordance with many embodiments of this invention alsocontain flour in order to make a dough or a batter. The term “dough” asused herein is a mixture of flour and other ingredients stiff enough toknead or roll. The term “batter” as used herein consists of flour,liquids such as milk or water, and other ingredients, and is thin enoughto pour or drop from a spoon. Desirably, in accordance with particularembodiments of the invention, the flour is present in the baked goods inan amount in the range of about 15 to about 60% on a dry weight basis,more desirably from about 23 to about 48% on a dry weight basis. Thetype of flour may be selected based on the desired product. Generally,the flour comprises an edible non-toxic flour that is conventionallyutilized in baked goods. According to particular embodiments, the flourmay be a bleached bake flour, general purpose flour, or unbleachedflour. In other particular embodiments, flours also may be used thathave been treated in other manners. For example, in particularembodiments flour may be enriched with additional vitamins, minerals, orproteins. Non-limiting examples of flours suitable for use in particularembodiments of the invention include wheat, corn meal, whole grain,fractions of whole grains (wheat, bran, and oatmeal), and combinationsthereof. Starches or farinaceous material also may be used as the flourin particular embodiments. Common food starches generally are derivedfrom potato, corn, wheat, barley, oat, tapioca, arrow root, and sago.Modified starches and pregelatinized starches also may be used inparticular embodiments of the invention.

The type of fat or oil used in particular embodiments of the inventionmay comprise any edible fat, oil, or combination thereof that issuitable for baking. Non-limiting examples of fats suitable for use inparticular embodiments of the invention include vegetable oils, tallow,lard, marine oils, and combinations thereof. According to particularembodiments, the fats may be fractionated, partially hydrogenated,and/or intensified. In another particular embodiment, the fat desirablycomprises reduced, low calorie, or non-digestible fats, fat substitutes,or synthetic fats. In yet another particular embodiment, shortenings,fats, or mixtures of hard and soft fats also may be used. In particularembodiments, shortenings may be derived principally from triglyceridesderived from vegetable sources (e.g., cotton seed oil, soybean oil,peanut oil, linseed oil, sesame oil, palm oil, palm kernel oil, rapeseedoil, safflower oil, coconut oil, corn oil, sunflower seed oil, andmixtures thereof). Synthetic or natural triglycerides of fatty acidshaving chain lengths from 8 to 24 carbon atoms also may be used inparticular embodiments. Desirably, in accordance with particularembodiments of this invention, the fat is present in the baked good inan amount in the range of about 2 to about 35% by weight on a dry basis,more desirably from about 3 to about 29% by weight on a dry basis.

Baked goods in accordance with particular embodiments of this inventionalso comprise water in amounts sufficient to provide the desiredconsistency, enabling proper forming, machining and cutting of the bakedgood prior or subsequent to cooking. The total moisture content of thebaked good includes any water added directly to the baked good as wellas water present in separately added ingredients (e.g., flour, whichgenerally includes about 12 to about 14% by weight moisture). Desirably,in accordance with particular embodiments of this invention, the wateris present in the baked good in an amount up to about 25% by weight ofthe baked good.

Baked goods in accordance with particular embodiments of this inventionalso may comprise a number of additional conventional ingredients suchas leavening agents, flavors, colors, milk, milk by-products, egg, eggby-products, cocoa, vanilla or other flavoring, as well as inclusionssuch as nuts, raisins, cherries, apples, apricots, peaches, otherfruits, citrus peel, preservative, coconuts, flavored chips such achocolate chips, butterscotch chips, and caramel chips, and combinationsthereof. In particular embodiments, the baked goods may also compriseemulsifiers, such as lecithin and monoglycerides.

According to particular embodiments of this invention, leavening agentsmay comprise chemical leavening agents or yeast leavening agents.Non-limiting examples of chemical leavening agents suitable for use inparticular embodiments of this invention include baking soda (e.g.,sodium, potassium, or aluminum bicarbonate), baking acid (e.g., sodiumaluminum phosphate, monocalcium phosphate, or dicalcium phosphate), andcombinations thereof.

In accordance with another particular embodiment of this invention,cocoa may comprise natural or “Dutched” chocolate from which asubstantial portion of the fat or cocoa butter has been expressed orremoved by solvent extraction, pressing, or other means. In a particularembodiment, it may be necessary to reduce the amount of fat in a bakedgood comprising chocolate because of the additional fat present in cocoabutter. In particular embodiments, it may be necessary to add largeramounts of chocolate as compared to cocoa in order to provide anequivalent amount of flavoring and coloring.

Baked goods generally also comprise caloric sweeteners, such as sucrose,high fructose corn syrup, erythritol, molasses, honey, or brown sugar.In exemplary embodiments of the baked goods provided herein, the caloricsweetener is replaced partially or totally with HSG-Extract or acomposition comprising HSG-Extract. Accordingly, in one embodiment abaked good comprises HSG-Extract or a composition comprising HSG-Extractin combination with a fat, water, and optionally flour. In a particularembodiment, the baked good optionally may include other natural and/orsynthetic high-potency sweeteners and/or bulk sweeteners.

Dairy Products

In one embodiment, the consumable of the present invention is a dairyproduct that comprises HSG-Extract. In another embodiment, theconsumable of the present invention is a dairy product that comprises acomposition comprising HSG-Extract. Dairy products and processes formaking dairy products suitable for use in this invention are well knownto those of ordinary skill in the art. Dairy products, as used herein,comprise milk or foodstuffs produced from milk. Non-limiting examples ofdairy products suitable for use in embodiments of this invention includemilk, milk cream, sour cream, crème fraiche, buttermilk, culturedbuttermilk, milk powder, condensed milk, evaporated milk, butter,cheese, cottage cheese, cream cheese, yogurt, ice cream, frozen custard,frozen yogurt, gelato, vla, piima, filmjölk, kajmak, kephir, viili,kumiss, airag, ice milk, casein, ayran, lassi, khoa, or combinationsthereof.

Milk is a fluid secreted by the mammary glands of female mammals for thenourishment of their young. The female ability to produce milk is one ofthe defining characteristics of mammals and provides the primary sourceof nutrition for newborns before they are able to digest more diversefoods. In particular embodiments of this invention, the dairy productsare derived from the raw milk of cows, goats, sheep, horses, donkeys,camels, water buffalo, yaks, reindeer, moose, or humans.

In particular embodiments of this invention, the processing of the dairyproduct from raw milk generally comprises the steps of pasteurizing,creaming, and homogenizing. Although raw milk may be consumed withoutpasteurization, it usually is pasteurized to destroy harmfulmicroorganisms such as bacteria, viruses, protozoa, molds, and yeasts.Pasteurizing generally comprises heating the milk to a high temperaturefor a short period of time to substantially reduce the number ofmicroorganisms, thereby reducing the risk of disease.

Creaming traditionally follows pasteurization step, and involves theseparation of milk into a higher-fat cream layer and a lower-fat milklayer. Milk will separate into milk and cream layers upon standing fortwelve to twenty-four hours. The cream rises to the top of the milklayer and may be skimmed and used as a separate dairy product.Alternatively, centrifuges may be used to separate the cream from themilk. The remaining milk is classified according to the fat content ofthe milk, non-limiting examples of which include whole, 2%, 1%, and skimmilk.

After removing the desired amount of fat from the milk by creaming, milkis often homogenized. Homogenization prevents cream from separating fromthe milk and generally involves pumping the milk at high pressuresthrough narrow tubes in order to break up fat globules in the milk.Pasteurization, creaming, and homogenization of milk are common but arenot required to produce consumable dairy products. Accordingly, suitabledairy products for use in embodiments of this invention may undergo noprocessing steps, a single processing step, or combinations of theprocessing steps described herein. Suitable dairy products for use inembodiments of this invention may also undergo processing steps inaddition to or apart from the processing steps described herein.

Particular embodiments of this invention comprise dairy productsproduced from milk by additional processing steps. As described above,cream may be skimmed from the top of milk or separated from the milkusing machine-centrifuges. In a particular embodiment, the dairy productcomprises sour cream, a dairy product rich in fats that is obtained byfermenting cream using a bacterial culture. The bacteria produce lacticacid during fermentation, which sours and thickens the cream. In anotherparticular embodiment, the dairy product comprises crème fraiche, aheavy cream slightly soured with bacterial culture in a similar mannerto sour cream. Crème fraiche ordinarily is not as thick or as sour assour cream. In yet another particular embodiment, the dairy productcomprises cultured buttermilk. Cultured buttermilk is obtained by addingbacteria to milk. The resulting fermentation, in which the bacterialculture turns lactose into lactic acid, gives cultured buttermilk a sourtaste. Although it is produced in a different manner, culturedbuttermilk generally is similar to traditional buttermilk, which is aby-product of butter manufacture.

According to other particular embodiments of this invention, the dairyproducts comprise milk powder, condensed milk, evaporated milk, orcombinations thereof. Milk powder, condensed milk, and evaporated milkgenerally are produced by removing water from milk. In a particularembodiment, the dairy product comprises a milk powder comprising driedmilk solids with a low moisture content. In another particularembodiment, the dairy product comprises condensed milk. Condensed milkgenerally comprises milk with a reduced water content and addedsweetener, yielding a thick, sweet product with a long shelf-life. Inyet another particular embodiment, the dairy product comprisesevaporated milk. Evaporated milk generally comprises fresh, homogenizedmilk from which about 60% of the water has been removed, that has beenchilled, fortified with additives such as vitamins and stabilizers,packaged, and finally sterilized. According to another particularembodiment of this invention, the dairy product comprises a dry creamerand HSG-Extract or a composition comprising HSG-Extract.

In another particular embodiment, the dairy product provided hereincomprises butter. Butter generally is made by churning fresh orfermented cream or milk. Butter generally comprises butterfatsurrounding small droplets comprising mostly water and milk proteins.The churning process damages the membranes surrounding the microscopicglobules of butterfat, allowing the milk fats to conjoin and to separatefrom the other parts of the cream. In yet another particular embodiment,the dairy product comprises buttermilk, which is the sour-tasting liquidremaining after producing butter from full-cream milk by the churningprocess.

In still another particular embodiment, the dairy product comprisescheese, a solid foodstuff produced by curdling milk using a combinationof rennet or rennet substitutes and acidification. Rennet, a naturalcomplex of enzymes produced in mammalian stomachs to digest milk, isused in cheese-making to curdle the milk, causing it to separate intosolids known as curds and liquids known as whey. Generally, rennet isobtained from the stomachs of young ruminants, such as calves; however,alternative sources of rennet include some plants, microbial organisms,and genetically modified bacteria, fungus, or yeast. In addition, milkmay be coagulated by adding acid, such as citric acid. Generally, acombination of rennet and/or acidification is used to curdle the milk.After separating the milk into curds and whey, some cheeses are made bysimply draining, salting, and packaging the curds. For most cheeses,however, more processing is needed. Many different methods may be usedto produce the hundreds of available varieties of cheese. Processingmethods include heating the cheese, cutting it into small cubes todrain, salting, stretching, cheddaring, washing, molding, aging, andripening. Some cheeses, such as the blue cheeses, have additionalbacteria or molds introduced to them before or during aging, impartingflavor and aroma to the finished product. Cottage cheese is a cheesecurd product with a mild flavor that is drained but not pressed so thatsome whey remains. The curd is usually washed to remove acidity. Creamcheese is a soft, mild-tasting, white cheese with a high fat contentthat is produced by adding cream to milk and then curdling to form arich curd. Alternatively, cream cheese can be made from skim milk withcream added to the curd. It should be understood that cheese, as usedherein, comprises all solid foodstuff produced by the curdling milk.

In another particular embodiment of this invention, the dairy productcomprises yogurt. Yogurt generally is produced by the bacterialfermentation of milk. The fermentation of lactose produces lactic acid,which acts on proteins in milk to give the yogurt a gel-like texture andtartness. In particularly desirable embodiments, the yogurt may besweetened with a sweetener and/or flavored. Non-limiting examples offlavorings include, but are not limited to, fruits (e.g., peach,strawberry, banana), vanilla, and chocolate. Yogurt, as used herein,also includes yogurt varieties with different consistencies andviscosities, such as dahi, dadih or dadiah, labneh or labaneh,bulgarian, kefir, and matsoni. In another particular embodiment, thedairy product comprises a yogurt-based beverage, also known as drinkableyogurt or a yogurt smoothie. In particularly desirable embodiments, theyogurt-based beverage may comprise sweeteners, flavorings, otheringredients, or combinations thereof.

Other dairy products beyond those described herein may be used inparticular embodiments of this invention. Such dairy products are wellknown to those of ordinary skill in the art, non-limiting examples ofwhich include milk, milk and juice, coffee, tea, vla, piima, filmjolk,kajmak, kephir, viili, kumiss, airag, ice milk, casein, ayran, lassi,and khoa.

According to particular embodiments of this invention, the dairycompositions also may comprise other additives. Non-limiting examples ofsuitable additives include sweeteners and flavorants such as chocolate,strawberry, and banana. Particular embodiments of the dairy compositionsprovided herein also may comprise additional nutritional supplementssuch as vitamins (e.g., vitamin D) and minerals (e.g., calcium) toimprove the nutritional composition of the milk.

In a particularly desirable embodiment, the dairy composition comprisesHSG-Extract or a composition comprising HSG-Extract in combination witha dairy product. In a particular embodiment, HSG-Extract is present inthe dairy composition in an amount in the range of about 200 to about20,000 weight percent of the dairy composition.

HSG-Extract or compositions comprising HSG-Extract is also suitable foruse in processed agricultural products, livestock products or seafood;processed meat products such as sausage and the like; retort foodproducts, pickles, preserves boiled in soy sauce, delicacies, sidedishes; soups; snacks such as potato chips, cookies, or the like; asshredded filler, leaf, stem, stalk, homogenized leaf cured and animalfeed.

Tabletop Sweetener Compositions

In one embodiment, the present invention is a tabletop sweetenercomprising HSG-Extract. The tabletop composition can further include atleast one bulking agent, additive, anti-caking agent, functionalingredient or combination thereof.

Suitable “bulking agents” include, but are not limited to, maltodextrin(10 DE, 18 DE, or 5 DE), corn syrup solids (20 or 36 DE), sucrose,fructose, glucose, invert sugar, sorbitol, xylose, ribulose, mannose,xylitol, mannitol, galactitol, erythritol, maltitol, lactitol, isomalt,maltose, tagatose, lactose, inulin, glycerol, propylene glycol, polyols,polydextrose, fructooligosaccharides, cellulose and cellulosederivatives, and the like, and mixtures thereof. Additionally, inaccordance with still other embodiments of the invention, granulatedsugar (sucrose) or other caloric sweeteners such as crystallinefructose, other carbohydrates, or sugar alcohol can be used as a bulkingagent due to their provision of good content uniformity without theaddition of significant calories.

As used herein, the phrase “anti-caking agent” and “flow agent” refer toany composition which assists in content uniformity and uniformdissolution. In accordance with particular embodiments, non-limitingexamples of anti-caking agents include cream of tartar, calciumsilicate, silicon dioxide, microcrystalline cellulose (Avicel, FMCBioPolymer, Philadelphia, Pa.), and tricalcium phosphate. In oneembodiment, the anti-caking agents are present in the tabletop sweetenercomposition in an amount from about 0.001 to about 3% by weight of thetabletop sweetener composition.

The tabletop sweetener compositions can be packaged in any form known inthe art. Non-limiting forms include, but are not limited to, powderform, granular form, packets, tablets, sachets, pellets, cubes, solids,and liquids.

In one embodiment, the tabletop sweetener composition is asingle-serving (portion control) packet comprising a dry-blend.Dry-blend formulations generally may comprise powder or granules.Although the tabletop sweetener composition may be in a packet of anysize, an illustrative non-limiting example of conventional portioncontrol tabletop sweetener packets are approximately 2.5 by 1.5 inchesand hold approximately 1 gram of a sweetener composition having asweetness equivalent to 2 teaspoons of granulated sugar (˜8 g). Theamount of HSG-Extract in a dry-blend tabletop sweetener formulation canvary. In a particular embodiment, a dry-blend tabletop sweetenerformulation may contain HSG-Extract in an amount from about 1% (w/w) toabout 10% (w/w) of the tabletop sweetener composition.

Solid tabletop sweetener embodiments include cubes and tablets. Anon-limiting example of conventional cubes are equivalent in size to astandard cube of granulated sugar, which is approximately 2.2×2.2×2.2cm³ and weigh approximately 8 g. In one embodiment, a solid tabletopsweetener is in the form of a tablet or any other form known to thoseskilled in the art.

A tabletop sweetener composition also may be embodied in the form of aliquid, wherein HSG-Extract is combined with a liquid carrier. Suitablenon-limiting examples of carrier agents for liquid tabletop sweetenersinclude water, alcohol, polyol, glycerin base or citric acid basedissolved in water, and mixtures thereof. The sweetness equivalent of atabletop sweetener composition for any of the forms described herein orknown in the art may be varied to obtain a desired sweetness profile.For example, a tabletop sweetener composition may comprise a sweetnesscomparable to that of an equivalent amount of standard sugar. In anotherembodiment, the tabletop sweetener composition may comprise a sweetnessof up to 100 times that of an equivalent amount of sugar. In anotherembodiment, the tabletop sweetener composition may comprise a sweetnessof up to 90 times, 80 times, 70 times, 60 times, 50 times, 40 times, 30times, 20 times, 10 times, 9 times, 8 times, 7 times, 6 times, 5 times,4 times, 3 times, and 2 times that of an equivalent amount of sugar.

Beverage and Beverage Products

In one embodiment, the present invention is a beverage or beverageproduct comprising HSG-Extract. In another embodiment, the presentinvention is a beverage or beverage comprising a composition thatcomprises HSG-Extract.

As used herein a “beverage product” is a ready-to-drink beverage, abeverage concentrate, a beverage syrup, or a powdered beverage. Suitableready-to-drink beverages include carbonated and non-carbonatedbeverages. Carbonated beverages include, but are not limited to,enhanced sparkling beverages, cola, lemon-lime flavored sparklingbeverage, orange flavored sparkling beverage, grape flavored sparklingbeverage, strawberry flavored sparkling beverage, pineapple flavoredsparkling beverage, ginger-ale, soft drinks and root beer.Non-carbonated beverages include, but are not limited to fruit juice,fruit-flavored juice, juice drinks, nectars, vegetable juice,vegetable-flavored juice, sports drinks, energy drinks, enhanced waterdrinks, enhanced water with vitamins, near water drinks (e.g., waterwith natural or synthetic flavorants), coconut water, tea type drinks(e.g. black tea, green tea, red tea, oolong tea), coffee, cocoa drink,beverage containing milk components (e.g. milk beverages, coffeecontaining milk components, café au lait, milk tea, fruit milkbeverages), beverages containing cereal extracts, smoothies andcombinations thereof.

Beverage concentrates and beverage syrups are prepared with an initialvolume of liquid matrix (e.g. water) and the desired beverageingredients. Full strength beverages are then prepared by adding furthervolumes of water. Powdered beverages are prepared by dry-mixing all ofthe beverage ingredients in the absence of a liquid matrix. Fullstrength beverages are then prepared by adding the full volume of water.

Beverages comprise a liquid matrix, i.e. the basic ingredient in whichthe ingredients—including the compositions of the present invention—aredissolved. In one embodiment, a beverage comprises water of beveragequality as the liquid matrix, such as, for example deionized water,distilled water, reverse osmosis water, carbon-treated water, purifiedwater, demineralized water and combinations thereof, can be used.Additional suitable liquid matrices include, but are not limited tophosphoric acid, phosphate buffer, citric acid, citrate buffer andcarbon-treated water.

In one embodiment, the consumable of the present invention is a beveragethat comprises a HSG-Extract.

In another embodiment, a beverage contains a composition comprisingHSG-Extract.

In a further embodiment, the present invention is a beverage productcomprising HSG-Extract.

In another embodiment, the present invention is a beverage product thatcontains a composition comprising HSG-Extract.

The concentration of HSG-Extract in the beverage may be above, at orbelow its threshold sweetness or recognition concentration.

In a particular embodiment, the concentration of HSG-Extract in thebeverage is above its threshold sweetness or flavor recognitionconcentration. In one embodiment, the concentration of HSG-Extract is atleast about 1%, at least about 5%, at least about 10%, at least about15%, at least about 20%, at least about 25%, at least about 30%, aboutleast about 35%, at least about 40%, about least about 45%, at leastabout 50% or more above its threshold sweetness or flavor recognitionconcentration.

In another particular embodiment, the concentration of HSG-Extract inthe beverage is at or approximately the threshold sweetness or flavorrecognition concentration of HSG-Extract.

In yet another particular embodiment, the concentration of HSG-Extractin the beverage is below the threshold sweetness or flavor recognitionconcentration of HSG-Extract. In one embodiment, the concentration ofHSG-Extract is at least about 1%, at least about 5%, at least about 10%,at least about 15%, at least about 20%, at least about 25%, at leastabout 30%, about least about 35%, at least about 40%, about least about45%, at least about 50% or more below its threshold sweetness or flavorrecognition concentration.

In one embodiment, the present invention is a beverage or beverageproduct that contains HSG-Extract in an amount ranging from about 1 ppmto about 10,000 ppm, such as, for example, from about 25 ppm to about800 ppm. In another embodiment, HSG-Extract is present in a beverage inan amount ranging from about 100 ppm to about 600 ppm. In yet otherembodiments, HSG-Extract is present in a beverage in an amount rangingfrom about 100 to about 200 ppm, from about 100 ppm to about 300 ppm,from about 100 ppm to about 400 ppm, or from about 100 ppm to about 500ppm. In still another embodiment, HSG-Extract is present in the beverageor beverage product in an amount ranging from about 300 to about 700ppm, such as, for example, from about 400 ppm to about 600 ppm. In aparticular embodiment, HSG-Extract is present in a beverage an amount ofabout 500 ppm.

The beverage can further include at least one additional sweetener. Anyof the sweeteners detailed herein can be used, including natural,non-natural, or synthetic sweeteners. These may be added to the beverageeither before, contemporaneously with or after HSG-Extract.

In one embodiment, the beverage contains a carbohydrate sweetener in aconcentration from about 100 ppm to about 140,000 ppm. Syntheticsweeteners may be present in the beverage in a concentration from about0.3 ppm to about 3,500 ppm. Natural high potency sweeteners may bepresent in the beverage in a concentration from about 0.1 ppm to about3,000 ppm.

The beverage can further comprise additives including, but not limitedto, carbohydrates, polyols, amino acids and their corresponding salts,poly-amino acids and their corresponding salts, sugar acids and theircorresponding salts, nucleotides, organic acids, inorganic acids,organic salts including organic acid salts and organic base salts,inorganic salts, bitter compounds, caffeine, flavorants and flavoringingredients, astringent compounds, proteins or protein hydrolysates,surfactants, emulsifiers, weighing agents, juice, dairy, cereal andother plant extracts, flavonoids, alcohols, polymers and combinationsthereof. Any suitable additive described herein can be used.

In one embodiment, the polyol can be present in the beverage in aconcentration from about 100 ppm to about 250,000 ppm, such as, forexample, from about 5,000 ppm to about 40,000 ppm.

In another embodiment, the amino acid can be present in the beverage ina concentration from about 10 ppm to about 50,000 ppm, such as, forexample, from about 1,000 ppm to about 10,000 ppm, from about 2,500 ppmto about 5,000 ppm or from about 250 ppm to about 7,500 ppm.

In still another embodiment, the nucleotide can be present in thebeverage in a concentration from about 5 ppm to about 1,000 ppm.

In yet another embodiment, the organic acid additive can be present inthe beverage in a concentration from about 10 ppm to about 5,000 ppm.

In yet another embodiment, the inorganic acid additive can be present inthe beverage in a concentration from about 25 ppm to about 25,000 ppm.

In still another embodiment, the bitter compound can be present in thebeverage in a concentration from about 25 ppm to about 25,000 ppm.

In yet another embodiment, the flavorant can be present in the beveragea concentration from about 0.1 ppm to about 4,000 ppm.

In a still further embodiment, the polymer can be present in thebeverage in a concentration from about 30 ppm to about 2,000 ppm.

In another embodiment, the protein hydrolysate can be present in thebeverage in a concentration from about 200 ppm to about 50,000.

In yet another embodiment, the surfactant additive can be present in thebeverage in a concentration from about 30 ppm to about 2,000 ppm.

In still another embodiment, the flavonoid additive can be present inthe beverage a concentration from about 0.1 ppm to about 1,000 ppm.

In yet another embodiment, the alcohol additive can be present in thebeverage in a concentration from about 625 ppm to about 10,000 ppm.

In a still further embodiment, the astringent additive can be present inthe beverage in a concentration from about 10 ppm to about 5,000 ppm.

The beverage can further contain one or more functional ingredients,detailed above. Functional ingredients include, but are not limited to,vitamins, minerals, antioxidants, preservatives, glucosamine,polyphenols and combinations thereof. Any suitable functional ingredientdescribed herein can be used.

It is contemplated that the pH of the consumable, such as, for example,a beverage, does not materially or adversely affect the taste of thesweetener. A non-limiting example of the pH range of the beverage may befrom about 1.8 to about 10. A further example includes a pH range fromabout 2 to about 5. In a particular embodiment, the pH of beverage canbe from about 2.5 to about 4.2. One of skill in the art will understandthat the pH of the beverage can vary based on the type of beverage.Dairy beverages, for example, can have pH greater than 4.2.

The titratable acidity of a beverage comprising HSG-Extract may, forexample, range from about 0.01 to about 1.0% by weight of beverage.

In one embodiment, the sparkling beverage product has an acidity fromabout 0.01 to about 1.0% by weight of the beverage, such as, forexample, from about 0.05% to about 0.25% by weight of beverage.

The carbonation of a sparkling beverage product has 0 to about 2% (w/w)of carbon dioxide or its equivalent, for example, from about 0.1 toabout 1.0% (w/w).

The temperature of a beverage may, for example, range from about 4° C.to about 100° C., such as, for example, from about 4° C. to about 25° C.

The beverage can be a full-calorie beverage that has up to about 120calories per 8 oz serving.

The beverage can be a mid-calorie beverage that has up to about 60calories per 8 oz serving.

The beverage can be a low-calorie beverage that has up to about 40calories per 8 oz serving.

The beverage can be a zero-calorie that has less than about 5 caloriesper 8 oz. serving.

Methods of Use

The compounds and compositions of the present invention can be used toimpart sweetness or to enhance the flavor or sweetness of consumables orother compositions.

In another aspect, the present invention is a method of preparing aconsumable comprising (i) providing a consumable matrix and (ii) addingHSG-Extract to the consumable matrix to provide a consumable.

In a particular embodiment, the present invention is a method ofpreparing a beverage comprising (i) providing a liquid or beveragematrix and (ii) adding HSG-Extract to the consumable matrix to provide abeverage.

In another aspect, the present invention is a method of preparing asweetened consumable comprising (i) providing a sweetenable consumableand (ii) adding HSG-Extract to the sweetenable consumable to provide asweetened consumable.

In a particular embodiment, the present invention is a method ofpreparing a sweetened beverage comprising (i) providing a sweetenablebeverage and (ii) adding HSG-Extract to the sweetenable beverage toprovide a sweetened beverage.

In the above methods, HSG-Extract may be provided as such, or in form ofa composition. When the HSG-Extract is provided as a composition, theamount of the composition is effective to provide a concentration ofHSG-Extract that is above, at or below its threshold flavor or sweetnessrecognition concentration when the composition is added to theconsumable (e.g., the beverage). When HSG-Extract is not provided as acomposition, it may be added to the consumable at a concentration thatis above, at or below its threshold flavor or sweetness recognitionconcentration.

In one embodiment, the present invention is a method for enhancing thesweetness of a consumable comprising (i) providing a consumablecomprising one or more sweet ingredients and (ii) adding HSG-Extract (1)to the consumable to provide a consumable with enhanced sweetness,wherein HSG-Extract is added to the consumable at a concentration at orbelow its threshold sweetness recognition concentration. In a particularembodiment, HSG-Extract is added to the consumable at a concentrationbelow its threshold sweetness recognition concentration.

In another embodiment, the present invention is a method for enhancingthe sweetness of a consumable comprising (i) providing a consumablecomprising one or more sweet ingredients and (ii) adding a compositioncomprising HSG-Extract to the consumable to provide a consumable withenhanced sweetness, wherein HSG-Extract is present in the composition inan amount effective to provide a concentration of HSG-Extract at orbelow its threshold sweetness recognition concentration when thecomposition is added to the consumable. In a particular embodiment,HSG-Extract is present in the composition in an amount effective toprovide a concentration of HSG-Extract below its threshold sweetnessrecognition concentration.

In a particular embodiment, the present invention is a method forenhancing the sweetness of a beverage comprising (i) providing abeverage comprising at least one sweet ingredient and (ii) addingHSG-Extract to the beverage to provide a beverage with enhancedsweetness, wherein HSG-Extract is added to the beverage in an amounteffective to provide a concentration at or below its threshold sweetnessrecognition concentration. In a particular embodiment, HSG-Extract isadded to the consumable in an amount effective to provide aconcentration below its threshold sweetness recognition concentration.

In another particular embodiment, the present invention is a method forenhancing the sweetness of a beverage comprising (i) providing abeverage comprising one or more sweet ingredients and (ii) adding acomposition comprising HSG-Extract to the consumable to provide abeverage with enhanced sweetness, wherein HSG-Extract is present in thecomposition in an amount effective to provide a concentration ofHSG-Extract at or below its threshold sweetness recognitionconcentration when the composition is added to the beverage. In aparticular embodiment, HSG-Extract is present in the composition in anamount effective to provide a concentration of HSG-Extract below itsthreshold sweetness recognition concentration when the composition isadded to the beverage.

In another embodiment, the present invention is method for enhancing theflavor of a consumable, comprising (i) providing a consumable comprisingat least one flavor ingredient and (ii) adding HSG-Extract to theconsumable to provide a consumable with enhanced flavor, whereinHSG-Extract is added to the consumable at a concentration at or belowits threshold flavor recognition concentration. In a particularembodiment, HSG-Extract is added to the consumable at a concentrationbelow its threshold flavor recognition concentration.

In another embodiment, the present invention is a method for enhancingthe flavor of a consumable comprising (i) providing a consumablecomprising at least one flavor ingredient and (ii) adding a compositionHSG-Extract to the consumable to provide a consumable with enhancedflavor, wherein HSG-Extract is present in the composition in an amounteffective to provide a concentration of HSG-Extract at or below itsthreshold flavor recognition concentration when the composition is addedto the consumable. In a particular embodiment, HSG-Extract is present inthe composition in an amount effective to provide a concentration ofHSG-Extract below its threshold flavor recognition concentration whenthe composition is added to the consumable.

In a particular embodiment, the present invention is a method forenhancing the flavor of a beverage comprising (i) providing a beveragecomprising at least one flavor ingredient and (ii) adding HSG-Extract tothe beverage to provide a beverage with enhanced flavor, whereinHSG-Extract is added to the beverage at a concentration at or below itsthreshold flavor recognition concentration. In a particular embodiment,HSG-Extract is added to the consumable at a concentration below itsthreshold flavor recognition concentration.

In a particular embodiment, the present invention is a method forenhancing the flavor of a beverage comprising (i) providing a beveragecomprising at least one flavor ingredient and (ii) adding a compositioncomprising HSG-Extract to the beverage to provide a beverage withenhanced flavor wherein HSG-Extract is present in the composition in anamount effective to provide a concentration of HSG-Extract at or belowits threshold flavor recognition concentration when the composition isadded to the beverage. In a particular embodiment, HSG-Extract ispresent in the composition in an amount effective to provide aconcentration of HSG-Extract below its threshold flavor recognitionconcentration when the composition is added to the consumable.

The present invention also includes methods of preparing sweetenedcompositions (e.g., sweetened consumables) and flavor enhancedcompositions (e.g., flavored enhanced consumables) by adding HSG-Extractor compositions comprising HSG-Extract to such compositions/consumables.

The following examples illustrate preferred embodiments of theinvention. It will be understood that the invention is not limited tothe materials, proportions, conditions and procedures set forth in theexamples, which are only illustrative.

Example 1

Preparation of Stevia Extracts

The extraction of Stevia rebaudiana dried leaves was carried outaccording to method described in U.S. Ser. No. 13/122,232 (Morita etal.).

100 g of dry leaves obtained from Stevia rebaudiana varieties, wasextracted several times with 20 times amount of water by weight untilthe sweetness cannot be tasted. The extract was passed through a columnfilled up with 300 mL of macroporous absorption resin (Diaion HP-20)wherein the steviol glycosides of the aqueous extract were absorbed tothe resin and the majority of other impurities pass through the columnwithout adsorbing to the resin. The resin was sufficiently washed withwater to remove the impurities, and the adsorbed steviol glycosides wereeluted with 900 mL of methanol. The eluate was passed through a columnfilled up with 200 mL of ion exchange resin (Diaion WA-30); 10 g ofactivated carbon was added to the eluate and stirred. The mixture wasfiltered, the filtrate was concentrated and the residue was dried togive Stevia extract comprising all the steviol glycosides originallypresent in the dried leaves of respective Stevia rebaudiana variety.

The obtained untreated aqueous extracts were used in variousapplications without any further purification, crystallization,separation, isolation of individual steviol glycosides.

Example 2

HPLC Assay

Any HPLC method or combination of HPLC methods capable of separatingeach steviol glycoside described herein can be used. The HPLC assayprocedures described by Morita et al., 2011, and Ohta et al., 2010 wereunable to separate properly the glycosides such as RebE, RebM, and RebD.Hence a HPLC methodology was developed to reliably determine andquantitate the steviol glycosides RebE, RebD, RebM, RebN, RebO, RebA,Stev, RebF, RebC, DulA, Rub, RebB, and Sbio. Each sample was analyzed by2 HPLC methods.

Method 1 was used for analysis of RebE, RebD, RebM, RebN, and RebO,while the Method 2 was used to analyze RebA, Stev, RebF, RebC, DulA,Rub, RebB, and Sbio. The reference standards for RebE, RebD, RebM, RebN,RebO and other steviol glycosides were purchased from ChromaDex Inc.(USA). Agilent 1200 HPLC system equipped with binary pump, autosampler,DAD detector interfaced with “Chemstation B” software was used.Alternatively any other equivalent HPLC system may be used as well.

Method 1 Instrument Conditions

Column: Agilent Poroshell 120 SB-C182.7 m, 4.6×150 mm

Column Temperature: 40° C.

Mobile Phase:

Solvent A 10 mM Monosodium dihydrogen Phosphate pH2.6: Acetonitrile,75%:25% (v/v)

Solvent B Water: Acetonitrile, 50%:50% (v/v)

Gradient program % v/v:

Time (min) A (%) B (%) 0.0 100 0 14.0 100 0 14.5 0 100 25.0 0 100Flow rate: 0.5 m/minInjection: 5 μLDetection: UV at 210 nmRuntime: 25 minPost time: 10 minAutosampler temperature: AmbientMethod 2 Instrument ConditionsColumn: Agilent Poroshell 120 SB-C182.7 m, 4.6×150 mm.Column Temperature: 40° C.Mobile phase: Isocratic 10 mM Monosodium dihydrogen Phosphate pH2.6:Acetonitrile, 68%:32% (v/v)Flow rate: 1.0 m/minInjection: 5 μLDetection: UV at 210 nmRuntime: 20 minAutosampler temperature: Ambient

The Table 1 summarizes the concentrations of steviol glycosides (%wt/wt, dry basis) in various extracts and leaves. The varieties 805082(high RebA) and 803066 (high Stevioside) are provided as controls. Itcan be seen that in extracts derived from common Stevia rebaudiana thehighest concentration of rebE, rebM, rebD, rebN and rebO are 0.9%,1.33%, 2.10%, 1.4% and 0.6% respectively. Meanwhile in the extractsderived from the Stevia rebaudiana cultivars of present invention theconcentration of rebE, rebM, RebD, rebN and rebO can reach up to 17.49%,7.64%, 23.04%, 4.87% and 5.85% respectively.

TABLE 1 Concentrations (% wt/wt, dry basis) of steviol glycosides inleaves and untreated aqueous extracts of leaves of common Steviarebaudiana varieties (Morita et al. 2011, Ohta et al., 2010) and thevarieties of the present invention Stevia rebaudiana variety Sbio RubDulA RebB Stev RebC RebF RebA RebE RebM RebD RebN RebO TSG Morita 0.771.52 0.92 0.69 40.71 9.95 1.90 40.19  0.09*  0.75** —** 0.23 0.05 97.77Variety A Morita 0.40 0.48 0.52 ND 26.21 9.18 1.63 54.94  0.26*  0.88**—** 0.27 0.09 94.85 Variety B Morita ND*** 0.57 0.15 2.10 7.12 7.69 1.6376.43 0.07  1.33** —** 0.54 0.30 97.93 Variety C Morita 4.87 1.62 2.300.75 55.92 6.30 1.28 21.82  0.50*  0.38** —** 0.06 ND 95.81 Variety STOhta et al., 1.00 0.80 0.30 2.50 9.20 7.50 1.90 61.60 0.30 1.00  2.101.40 0.60 90.20 Morita leaf extract Ohta et al., 5.00 ND 2.60 2.00 49.806.80 1.40 21.50 0.90 ND 0.40 0.10 ND 90.50 Bertoni leaf extract 814011ND ND ND ND 3.73 4.52 1.52 61.55 ND 7.64  8.92 1.68 5.85 95.41 Extract807086 ND ND ND ND 6.20 4.33 1.81 49.29 0.85 7.44  16.58 3.58 5.78 95.86Extract 817096 ND ND ND ND 22.86 3.58 0.97 16.10 17.49  3.87  23.04 4.873.25 96.03 Extract 805082 0.13 0.10 0.14 0.55 4.78 5.60 1.14 80.25 0.080.48  1.27 0.04 0.54 95.10 Extract 803066 0.55 0.16 7.71 ND 84.36 0.240.19 2.24 ND 0.07  0.08 ND ND 95.60 Extract 814011 dry ND ND ND ND 0.460.55 0.18 7.41 ND 0.93  1.06 0.20 0.70 11.49 leaves 807086 dry ND ND NDND 0.44 0.32 0.13 3.55 0.06 0.53  1.20 0.26 0.41 6.90 leaves 817096 dryND ND ND ND 2.31 0.35 0.10 1.61 1.75 0.38  2.32 0.48 0.32 9.62 leaves805082 dry 0.02 0.02 0.02 0.07 0.65 0.76 0.15 10.78 0.01 0.07  0.18 0.050.07 12.85 leaves 803066 dry 0.07 0.02 0.93 ND 10.03 0.03 0.02 0.26 ND0.01  0.01 ND ND 11.38 leaves *in Morita et al., 2011 the Variety A RebEpeak is labeled as “III + Rebau E”; Varieties B and ST RebE peaks arelabeled as “Rebau E + III + IV” **in Morita et al., 2011 the VarietiesA, B, C, and ST RebM peaks are labeled as “Rebaud D + VIII” ***ND—NotDetected (the concentration is below detection limit)

Table 2 summarizes the relative concentrations of steviol glycosides (%)in various extracts and leaves. It can be seen that in extracts derivedfrom common Stevia rebaudiana the highest relative concentration ofrebE, rebM, RebD, rebN and rebO are 0.99%, 1.36%, 2.33%, 1.55% and 0.67%respectively. Meanwhile in the extracts derived from the Steviarebaudiana cultivars of present invention the relative concentration ofrebE, rebM, RebD, rebN and rebO can reach up to 18.21%, 8.01%, 23.99%,5.07% and 6.13% respectively.

TABLE 2 Relative Concentrations (%) of steviol glycosides in leaves anduntreated aqueous extracts of leaves of common Stevia rebaudianavarieties (Morita et al. 2011, Ohta et al., 2010) and the varieties ofthe present invention Stevia rebaudiana variety Sbio Rub DulA RebB StevRebC RebF RebA RebE RebM RebD RebN RebO Variety A 0.79 1.56 0.94 0.7141.64 10.18 1.94 41.11  0.09* 0.76** —** 0.23 0.05 Extract Variety B0.42 0.50 0.55 ND 27.63 9.68 1.72 57.92  0.27* 0.93** —** 0.28 0.09Extract Variety C ND 0.58 0.15 2.14 7.27 7.85 1.66 78.05 0.07 1.36** —**0.55 0.31 Extract Variety ST 5.08 1.69 2.40 0.78 58.37 6.58 1.34 22.78 0.52* 0.40** —** 0.06 ND Extract Ohta et al., 1.11 0.89 0.33 2.77 10.208.31 2.11 68.29 0.33 1.11   2.33 1.55 0.67 Morita leaf extract Ohta etal., 5.52 ND 2.87 2.21 55.03 7.51 1.55 23.76 0.99 ND 0.44 0.11 NDBertoni leaf extract 814011 ND ND ND ND 3.91 4.74 1.59 64.51 ND 8.01  9.35 1.76 6.13 Extract 807086 ND ND ND ND 6.47 4.52 1.89 51.42 0.897.76   17.30 3.73 6.03 Extract 817096 ND ND ND ND 23.81 3.73 1.01 16.7718.21  4.03   23.99 5.07 3.38 Extract 805082 0.14 0.11 0.15 0.58 5.035.89 1.20 84.39 0.08 0.50   1.34 0.04 0.57 Extract 803066 0.58 0.17 8.06ND 88.24 0.25 0.20 2.34 ND 0.07   0.08 ND ND Extract 814011 dry ND ND NDND 4.00 4.79 1.57 64.49 ND 8.09   9.23 1.74 6.09 leaves 807086 dry ND NDND ND 6.38 4.64 1.88 51.45 0.87 7.68   17.39 3.77 5.94 leaves 817096 dryND ND ND ND 24.01 3.64 1.04 16.74 18.19  3.95   24.12 4.99 3.33 leaves805082 dry 0.16 0.16 0.16 0.54 5.06 5.91 1.17 83.89 0.08 0.54   1.400.39 0.54 leaves 803066 dry 0.62 0.18 8.17 ND 88.14 0.26 0.18 2.28 ND0.09   0.09 ND ND leaves *in Morita et al., 2011 the Variety A RebE peakis labeled as “III + Rebau E”; Varieties B and ST RebE peaks are labeledas “Rebau E + III + IV” **in Morita et al., 2011 the Varieties A, B, C,and ST RebM peaks are labeled as “Rebaud D + VIII” ***ND—Not Detected(the concentration is below detection limit)

Example 3

Low-Caloric Orange Juice Drink

Orange concentrate (35%), citric acid (0.35%), ascorbic acid (0.05%),orange red color (0.01%), orange flavor (0.20%), Rebaudioside A (0.003%)and different steviol glycosides compositions (0.03%) were blended anddissolved completely in water (up to 100%) and pasteurized. HSG-extractsand regular extracts were used as steviol glycoside compositions.HSG-extracts were represented by untreated aqueous extracts of Steviarebaudiana 814011, 807086, 817096 while common extracts were representedby untreated aqueous extracts of Stevia rebaudiana 805082, 803066,obtained according to EXAMPLE 1.

The sensory evaluations of the samples are summarized in Table 3. Thedata show that the best results can be obtained by using the HSGextracts. Particularly the drinks prepared with HSG-Extracts exhibited arounded and complete flavor profile and mouthfeel.

TABLE 3 Evaluation of orange juice drink samples Extract Comments SampleFlavor Aftertaste Mouthfeel 814011 High quality sweetness, Clean, nobitterness Full pleasant taste similar to and no aftertaste sucrose,rounded and balanced flavor 807086 High quality sweetness, Clean, nobitterness Full pleasant taste similar to and no aftertaste sucrose,rounded and balanced flavor 817096 High quality sweetness, Clean, almostno Full pleasant taste similar to bitterness, sucrose, rounded and noaftertaste balanced flavor 805082 Sweet, licorice notes Moderatebitterness Not and aftertaste acceptable 803066 Sweet, licorice notesSignificant bitterness Not and aftertaste acceptable

The same method can be used to prepare juices and juice drinks fromother fruits, such as apples, lemons, apricots, cherries, pineapples,mangoes, etc.

Example 4

Low-Calorie Carbonated Beverage

A carbonated beverage according to formula presented below was prepared.

Ingredients Quantity, % Sucrose 5.5 Cola flavor 0.340 ortho-Phosphoricacid 0.100 Sodium citrate 0.310 Sodium benzoate 0.018 Citric acid 0.018Steviol glycosides composition 0.053 Carbonated water to 100

HSG-extracts and regular extracts were used as steviol glycosidecompositions. HSG-extracts were represented by untreated aqueousextracts of Stevia rebaudiana 814011, 807086, 817096 while commonextracts were represented by untreated aqueous extracts of Steviarebaudiana 805082, 803066, obtained according to EXAMPLE 1.

The sensory properties were evaluated by 20 panelists. The results aresummarized in Table 4.

TABLE 4 Evaluation of low-calorie carbonated beverage samples TasteNumber of panelists detected the attribute attribute 814011 807086817096 805082 803066 Bitter taste 0 0 0 15 17 Astringent 0 1 0 14 16taste Aftertaste 2 2 3 14 18 Comments Quality of Clean Clean Clean CleanClean sweet taste (20 of 20) (20 of 20) (20 of 20) (2 of 20) (0 of 20)Overall Satisfactory Satisfactory Satisfactory Satisfactory Satisfactoryevaluation (20 of 20) (20 of 20) (20 of 20) (2 of 20) (0 of 20)

The above results show that the beverage prepared using HSG-Extractspossessed the best organoleptic characteristics.

Example 5

Diet Cookies

Flour (50.0%), margarine (30.0%) fructose (10.0%), maltitol (8.0%),whole milk (1.0%), salt (0.2%), baking powder (0.15%), vanillin (0.1%)and different steviol glycoside compositions (0.03%) were kneaded wellin dough-mixing machine. The obtained dough was molded and baked in ovenat 200° C. for 15 minutes. HSG-extracts and regular extracts were usedas steviol glycoside compositions. HSG-extracts were represented byuntreated aqueous extracts of Stevia rebaudiana 814011, 807086, 817096while common extracts were represented by untreated aqueous extracts ofStevia rebaudiana 805082, 803066, obtained according to EXAMPLE 1.

The sensory properties were evaluated by 20 panelists. The best resultswere obtained in samples prepared by HSG-Extracts. The panelists notedrounded and complete flavor profile and mouthfeel in cookies preparedwith HSG-Extracts.

Example 6

Yoghurt

Different steviol glycoside compositions (0.03%) and sucrose (4%) weredissolved in low fat milk. HSG-extracts and regular extracts were usedas steviol glycoside compositions. HSG-extracts were represented byuntreated aqueous extracts of Stevia rebaudiana 814011, 807086, 817096while common extracts were represented by untreated aqueous extracts ofStevia rebaudiana 805082, 803066, obtained according to EXAMPLE 1. Afterpasteurizing at 82° C. for 20 minutes, the milk was cooled to 37° C. Astarter culture (3%) was added and the mixture was incubated at 37° C.for 6 hours then at 5° C. for 12 hours.

The sensory properties were evaluated by 20 panelists. The best resultswere obtained in samples prepared by HSG-extracts. The panelists notedrounded and complete flavor profile and mouthfeel in sample preparedwith HSG-extracts.

It is to be understood that the foregoing descriptions and specificembodiments shown herein are merely illustrative of the best mode of theinvention and the principles thereof, and that modifications andadditions may be easily made by those skilled in the art withoutdeparting for the spirit and scope of the invention, which is thereforeunderstood to be limited only by the scope of the appended claims.

The invention claimed is:
 1. A process for preparing steviol glycosidecompositions, comprising the steps of: a) providing Stevia rebaudianaleaves, wherein the Stevia rebaudiana leaves are obtained from acultivar that has been selectively bred to yield leaves that compriseRebM in an amount above a common relative concentration of RebM; b)providing a solvent comprising water; c) contacting the Steviarebaudiana leaves with solvent to extract the steviol glycosides fromthe leaves; and d) separating the Stevia rebaudiana leaves to obtainStevia extract solution comprising RebM, wherein the RebM is present inthe solution above its common relative concentration; and wherein forRebM the common relative concentration is 1.4%.
 2. The process of claim1 further comprising purification of the Stevia extract solution anddrying to obtain a Stevia extract with total steviol glycoside contentof at least 6.9% (wt/wt on dry basis).
 3. The process of claim 1 whereinStevia rebaudiana leaves are obtained from at least one Steviarebaudiana cultivar selected from the group consisting of: ‘807086’wherein a representative sample of live plant tissue of said ‘807086’cultivar has been deposited under CGMCC No. 9702; ‘814011’ wherein arepresentative sample of live plant tissue of said ‘814011’ cultivar hasbeen deposited under CGMCC No. 9701; and ‘817096’ wherein arepresentative sample of live plant tissue of said ‘817096’ cultivar hasbeen deposited under CGMCC No.
 9703. 4. The process of claim 1 whereinStevia rebaudiana leaves are obtained from a cultivar generated using atleast one Stevia rebaudiana cultivar selected from group consisting of:‘807086’ wherein a representative sample of live plant tissue of said‘807086’ cultivar has been deposited under CGMCC No. 9702; ‘814011’wherein a representative sample of live plant tissue of said ‘814011’cultivar has been deposited under CGMCC No. 9701; and ‘817096’ wherein arepresentative sample of live plant tissue of said ‘817096’ cultivar hasbeen deposited under CGMCC No.
 9703. 5. An untreated aqueous Steviaextract prepared by the process of claim 1, wherein RebM is present inthe extract at or above its common relative concentration.
 6. A food,beverage or other consumable comprising Stevia extract of claim 5.